## Protocol Section
### Identification Module
**NCT ID:** NCT06418685

**Acronym:** RWS-VC

**Brief Title:** Real-World Clinical Study on the Efficacy of Vibrating Capsule (Vibrabot Capsule) for Chronic Functional Constipation

**Official Title:** The First Affiliated Hospital of Naval Medical University

#### Organization Study ID Info
**ID:** ANKONYX2023006
#### Organization
**Class:** OTHER
**Full Name:** Changhai Hospital
### Status Module
#### Completion Date
**Date:** 2026-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-30
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Ruijin Hospital

**Class:** OTHER

**Name:** Shanghai Tongji Hospital, Tongji University School of Medicine

**Class:** OTHER

**Name:** Shanghai 10th People's Hospital

**Class:** OTHER

**Name:** Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

**Class:** OTHER

**Name:** Shanghai 6th People's Hospital

**Class:** OTHER

**Name:** Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

**Class:** OTHER

**Name:** Shanghai Pudong New Area Gongli Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Changhai Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study is a multi-center prospective cohort study, which plans to include 300 patients with chronic functional constipation to treat with Vibrabot capsules, and at the same time, include ≥300 patients receiving constipation treatment during the same period.

During the study, it is necessary to collect the patients' basic information, baseline constipation status and treatment information, capsule intake during treatment, and concomitant medication. During the treatment phase, patients follow the doctor's advice to receive Vibrabot capsule treatment and maintain stable dietary intake and exercise according to the constipation diagnosis and treatment guidelines.

During the study, patients need to scan the two-dimensional code or search for the electronic questionnaire "Vibrabot Health" Official Account on WeChat, and fill in the relevant information during the treatment in the electronic questionnaire in a timely and truthful manner. The treatment effect of the patients is evaluated by assessing the number of occurrences of spontaneous bowel movements (SBM) and complete spontaneous bowel movements (CSBM).

**Detailed Description:** Constipation is characterized by a decrease in bowel movements, dry and hard stools, and difficulty in defecation. With changes in diet, faster pace of life, and social psychological factors, the prevalence of chronic constipation is on the rise. The global incidence of chronic constipation is 14%, while the prevalence of chronic constipation in adults in China is 4.0% to 10.0%. The prevalence of functional constipation in China is 6%. The high-risk groups for constipation include the elderly, women, diabetics, those taking opiates, antipsychotic drugs, or bedridden patients. Occupation, lifestyle, dietary habits, mental health, family history of constipation, and BMI are factors related to constipation.

Constipation affects patients' quality of life, and some patients abuse laxatives or repeatedly seek medical treatment, increasing medical costs. The main treatments for constipation are adjusting lifestyle, medication, psychotherapy, biofeedback, and surgery. However, these methods often have side effects, and patient satisfaction is still relatively low. A new approach needs to be explored to address this clinical problem.

The Disposable Gastrointestinal Vibrating Capsule System (Vibrabot capsule) (NMPA Device Approval No. 20223090282) is the world's first approved and marketed product for treating constipation through purely physical means. It can provide intermittent comfortable massages to the digestive tract, activate the intestinal neural network, awaken intestinal motility, and help alleviate constipation issues. Clinical study results show that the product is safe to use and can increase the frequency of bowel movements in patients with chronic functional constipation.

This study focuses on post-marketing clinical study for patients with functional constipation of varying severity, further evaluating the efficacy of the product in a large sample population.

Through this real-world study, to analyze the response of functional constipation patients with different severity, treatment status, capsule dosage, and combined medication to Vibrabot capsule, as well as the duration of efficacy maintenance during the follow-up period; to compare the efficacy with patients treated with drugs or other therapies during the same period, explore the possibility of curing functional constipation patients, further improve the treatment satisfaction of constipation patients, and promote the establishment and application of consensus or guidelines for the use of Vibrabot capsule in treating functional constipation.

Each patient will undergo a series of study visits, including screening, treatment visit, and follow-up visit. The visit process is briefly described as follows:

Visit 1 (0 \~ 1 day) - Baseline/Screening Period:

This visit includes:

The patient will sign an informed consent form; Set the inclusion/exclusion criteria; Guide patients to fill out the questionnaire using the Official Account and complete the Baseline Period Questionnaire in the Official Account.

Prescription Vibrabot capsule treatment or other treatment options.

Visit 2 (Week 2 ±3 days) - Treatment Period 1:

This visit includes:

Fill out the Daily Bowel Movement Questionnaire in the WeChat Official Account every day, take Vibrabot capsules on time or opt for other treatment plans; Fill out the Constipation Symptom Self-Assessment Scale and Assessment Scale for Quality of Life with Constipation in the Official Account every 2 treatment weeks.

Record adverse events and concomitant treatments; Prescription Vibrabot capsules or other treatment options. Visit 3 (Week 4±3 days) - Treatment Period 2

This visit includes:

Fill out the Daily Bowel Movement Questionnaire in the WeChat Official Account every day, take Vibrabot capsules on time or opt for other treatment plans; Fill out the Constipation Symptom Self-Assessment Scale and Assessment Scale for Quality of Life with Constipation in the Official Account every 2 treatment weeks.

Record adverse events and concomitant treatments; Prescription Vibrabot capsules or other treatment options. Visit 4 (Week 6 ±3 days) - Treatment Period 3

This visit includes:

Fill out the Daily Bowel Movement Questionnaire in the WeChat Official Account every day, take Vibrabot capsules on time or opt for other treatment plans; Fill out the Constipation Symptom Self-Assessment Scale and Assessment Scale for Quality of Life with Constipation in the Official Account every 2 treatment weeks.

Record adverse events and concomitant treatments.

Visit 5 (Week 10±3 days) - Follow-up Period:

This visit includes:

Fill out the Daily Bowel Movement Questionnaire in the WeChat Official Account every day; Fill out the Constipation Symptom Self-Assessment Scale and Assessment Scale for Quality of Life with Constipation in the Official Account every 2 treatment weeks; Record adverse events and concomitant treatments.

### Conditions Module

**Conditions:**

- Clinical Study

- Chronic Functional Constipation

**Keywords:**

- Real-World Clinical Study

- Vibrating Capsule

- Chronic Functional Constipation

- Response Rate

- Complete Spontaneous Bowel Movement

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Treatment with Vibrabot Capsule

**Intervention Names:**

- Device: Treatment with Vibrating Capsule

**Label:** VC group

#### Arm Group 2

**Description:** Selecting Alternative Treatment Methods through Assessment

**Label:** Other treatment group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- VC group

**Description:** Main parameters of Vibrabot capsule: nominal diameter: 11.8±1mm; nominal length: 26.7±1mm; nominal weight: 4.5±1g.

After the patient swallows the Vibrabot capsule, the capsule runs through the stomach → duodenum → jejunum and ileum → colon. According to the clinical data and configuration settings, the capsule will reach the colon and vibrate 8 hours after activation for ≥ 180 minutes in a cycle at low, medium, and high frequencies sequentially. The capsule relieves and treats constipation by massaging the colon wall through motor vibration to relieve colon muscle spasms and promote colonic peristalsis.

The VC well be taken between 21:00 and 22:00 every day, and the frequency of administration is determined based on the patient's individual situation.

**Name:** Treatment with Vibrating Capsule

**Type:** DEVICE

### Outcomes Module

#### Other Outcomes

**Description:** Collect relevant data through baseline questionnaire.

**Measure:** Proportion of constipated patients (including different constipation types, occupations, age groups, BMI, gender, and baseline treatment status) responding to vibrating capsule treatment.

**Time Frame:** At the end of the sixth week of treatment

**Description:** Collect relevant data through baseline questionnaire.

**Measure:** occupations, age groups, BMI, gender, and baseline treatment status) responding to vibrating capsule treatment.

**Time Frame:** at the end of the 4-week follow-up period.

#### Primary Outcomes

**Description:** The definition of the responder is a patient with an average weekly increase of ≥1 complete spontaneous bowel movement (CSBM) compared to the baseline.

**Measure:** After treatment, whether the response rate of patients using the Vibrabot vibrating capsules alone reaches 50%.

**Time Frame:** At the end of the sixth week of treatment

#### Secondary Outcomes

**Description:** Collect relevant data through daily defecation questionnaires.

**Measure:** Proportion of constipated patients who use/do not use other constipation treatment methods

**Time Frame:** At the end of the sixth week of treatment

**Description:** Collect relevant data through daily defecation questionnaires.

**Measure:** Proportion of constipated patients who use/do not use other constipation treatment methods

**Time Frame:** at the end of the 4-week follow-up

**Description:** Collect relevant data through daily defecation questionnaires,CSBM refers to spontaneous defecation without anal obstruction and without taking laxatives within 24 hours before defecation.

**Measure:** Proportion of patients with an average increase of ≥1 CSBMs per week compared to the baseline period

**Time Frame:** At the end of the sixth week of treatment

**Description:** Collect relevant data through daily defecation questionnaires, SBM refers to spontaneous defecation without taking laxatives within 24 hours before defecation.

**Measure:** Proportion of respondents with an average of ≥3 SBMs per week during the treatment period

**Time Frame:** At the end of the sixth week of treatment

**Description:** Collect relevant data through daily defecation questionnaires, SBM refers to spontaneous defecation without taking laxatives within 24 hours before defecation.CSBM refers to spontaneous defecation without anal obstruction and without taking laxatives within 24 hours before defecation.

**Measure:** Proportion of subjects with ≥3 SBMs per week and an increase of ≥1 CSBMs during at least 4 weeks of treatment compared to baseline

**Time Frame:** At the end of the sixth week of treatment

**Description:** Collect relevant data through daily defecation questionnaires.

**Measure:** Proportion of patients with an average increase of ≥1 CSBMs per week during the follow-up phase compared to the baseline period;

**Time Frame:** At the end of the sixth week of treatment

**Description:** Collect relevant data through daily defecation questionnaires.

**Measure:** Proportion of patients with an average of ≥3 SBMs per week during the follow-up phase

**Time Frame:** at the end of the 4-week follow-up

**Description:** Collect relevant data through daily defecation questionnaires. Patient Assessment of Constipation Quality of Life questionnaire，The PAC-QoL questionnaire consists of 28 items, each with a score of 0 to 4, measuring anxiety, physical discomfort, psychosocial discomfort, and treatment satisfaction, respectively The higher the score, the worse the quality of life.

**Measure:** Proportion of patients with a reduction of ≥1 point in total Patient Assessment of Constipation Quality of Life questionnaire(PAC-QOL) scores after treatment compared to the baseline period

**Time Frame:** At the end of the sixth week of treatment

**Description:** Collect relevant data through daily defecation questionnaires.The PAC-SYM questionnaire consists of 12 items, each with a score of 0 to 4, quantifying stool symptoms, rectal symptoms, and abdominal symptoms. The higher the score, the more constipation symptoms will be serious.

**Measure:** Proportion of patients with a reduction of ≥1 point in total Patient Assessment of Constipation Symptom (PAC-SYM) scores after treatment compared to the baseline period

**Time Frame:** At the end of the sixth week of treatment

**Description:** Collect relevant data through daily defecation questionnaires.

**Measure:** Time of first use of laxative or enema after a course of vibrating capsule treatment (6 weeks)

**Time Frame:** After the end of the sixth week of treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Patients who can be diagnosed with functional constipation according to the Rome IV criteria.
2. Patients who consent to participate in this trial and voluntarily sign the informed consent form (ICF).

Exclusion Criteria:

1. People who are not eligible for surgery or refuse to undergo any abdominal surgery;
2. People with known or suspected gastrointestinal obstruction, stenosis, diverticulum, bleeding, malformation, and fistula.
3. People allergic to polymeric materials;
4. People implanted with cardiac pacemakers and using gastrointestinal pacemakers;
5. People with abdominal aortic aneurysms, gastrointestinal vascular lesions, ulcers, and lesions with bleeding tendencies.
6. People with dysphagia;
7. Pregnant women;
8. People with severe depression and anxiety and severe acute gastrointestinal lesions.
9. People with other conditions, so the investigator considers them not eligible for this study.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** This study is a multi-center clinical trial. Patients are considered eligible for this study if they meet the inclusion criteria and do not meet any of the exclusion criteria. This study plans to include 300 patients with chronic functional constipation to treat with Vibrabot capsules for at least 6 weeks, and ≥300 patients with constipation receiving other treatments concurrently.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drfionachien@163.com

**Name:** Yangyang Qian, MD

**Phone:** +86 13818040017

**Role:** CONTACT

**Contact 2:**

**Email:** jiahuizhu2685@126.com

**Name:** Jiahui Zhu, MD

**Phone:** +86 18301952685

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Email:** liaozhuan@smmu.edu.cn

- **Name:** Zhuan Liao, MD

- **Phone:** 86-21-31161004

- **Role:** CONTACT

**Country:** China

**Facility:** Changhai hospital

#### Overall Officials

**Official 1:**

**Affiliation:** Changhai Hospital

**Name:** Zhuan Liao, MD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** Scott SM, Simren M, Farmer AD, Dinning PG, Carrington EV, Benninga MA, Burgell RE, Dimidi E, Fikree A, Ford AC, Fox M, Hoad CL, Knowles CH, Krogh K, Nugent K, Remes-Troche JM, Whelan K, Corsetti M. Chronic constipation in adults: Contemporary perspectives and clinical challenges. 1: Epidemiology, diagnosis, clinical associations, pathophysiology and investigation. Neurogastroenterol Motil. 2021 Jun;33(6):e14050. doi: 10.1111/nmo.14050. Epub 2020 Dec 2.

**PMID:** 33263938

**Citation:** Zhu JH, Qian YY, Pan J, He C, Lan Y, Chen WN, Wang BM, Zhao W, Li JN, Li XQ, Lv B, Fan YH, Zuo XL, Li Z, Zou DW, Li ZS, Liao Z. Efficacy and safety of vibrating capsule for functional constipation (VICONS): A randomised, double-blind, placebo-controlled, multicenter trial. EClinicalMedicine. 2022 Apr 25;47:101407. doi: 10.1016/j.eclinm.2022.101407. eCollection 2022 May.

**PMID:** 35518121

**Citation:** Camilleri M, Kerstens R, Rykx A, Vandeplassche L. A placebo-controlled trial of prucalopride for severe chronic constipation. N Engl J Med. 2008 May 29;358(22):2344-54. doi: 10.1056/NEJMoa0800670.

**PMID:** 18509121

## Document Section

### Large Document Module

#### Large Docs

- Date: 2023-07-18

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 6781938

- Type Abbrev: Prot_SAP

- Upload Date: 2024-05-15T12:54

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012817

- Term: Signs and Symptoms, Digestive

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M6472

- Name: Constipation

- Relevance: HIGH

- As Found: Constipation

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003248

- Term: Constipation

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T120

- Name: Cola

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
