## Protocol Section
### Identification Module
**NCT ID:** NCT05585879

**Brief Title:** Demonstrating Effective Salvage of Inadequate Colonoscopies

**Official Title:** Outpatient Colonoscopy: Demonstrating Effective Salvage of Inadequate Colonoscopies Utilizing the Pure-Vu EVS System

#### Organization Study ID Info
**ID:** CL00052
#### Organization
**Class:** INDUSTRY
**Full Name:** Motus GI Medical Technologies Ltd
### Status Module
#### Completion Date
**Date:** 2024-04-26

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-13

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2024-04-26

**Type:** ACTUAL

#### Start Date
**Date:** 2022-11-03

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2022-10-19
**Type:** ACTUAL
**Study First Submit Date:** 2022-09-23
**Study First Submit QC Date:** 2022-10-14
**Why Stopped:** Strategy changed
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Motus GI Medical Technologies Ltd

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The aim of this study is to demonstrate that the use of the Pure-Vu EVS System can salvage inadequately prepared optical colonoscopies (OCs) to adequate OCs.

**Detailed Description:** The primary objective of this study is to demonstrate the reduction of inadequate colonoscopies when Pure-Vu EVS System is used to salvage inadequately prepped colons as defined by the multi-society guidelines (USMSTF).

### Conditions Module

**Conditions:**

- Colorectal Screening

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Multicenter, Prospective, Consecutive Series, Pragmatic Clinical Trial

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 16

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Rate of incomplete colonoscopies due to inadequate preparation salvaged to adequate colonoscopies with the use of the Pure-Vu EVS System.

Inadequate OCs defined as such if any of the following are met:

* BBPS \< 6 (Adequacy is defined as BBPS of 2 or greater in each segment)
* Inability to identify \> 5mm polyps The estimated rate of salvaged preparations will be calculated and presented with exact one-sided 95% confidence interval: Number of preps inadequate with SOC and adequate after Pure-VU EVS System / Number of preps inadequate with SOC.

The lower bound will be compared to a 35% performance goal.

**Intervention Names:**

- Device: Pure-Vu EVS

**Label:** Pure-Vu EVS

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Pure-Vu EVS

**Description:** Subjects will be enrolled until 115 inadequate bowel prep cases via SOC are accrued and subsequently treated with Pure-Vu EVS. Inadequate OCs defined as such if any of the following are met:

* Boston Bowel Preparation Score (BBPS) \< 6 (Adequacy is defined as BBPS of 2 or greater in each segment)
* Inability to identify \> 5mm polyps

**Name:** Pure-Vu EVS

**Type:** DEVICE

### Outcomes Module

#### Other Outcomes

**Description:** Clinician Satisfaction Questionnaire: Each clinician will complete a questionnaire for each completed Pure-Vu EVS procedure.

**Measure:** User Satisfaction

**Time Frame:** Day 0(Procedure Day)

**Description:** Comparison of SAE rates between Pure-Vu subjects and the published serious complication rate of standard colonoscopy procedures (2.8%)

**Measure:** Comparison Rates

**Time Frame:** Day 0 (Procedure Day) - 1-14 day follow up

**Description:** Economic Impact: Impact will be calculated by utilizing both data generated as part of the study and data published on the costs associated with outpatient colonoscopies and subsequent findings.

**Measure:** Economic Impact

**Time Frame:** Through study completion, an average of 1 year.

#### Primary Outcomes

**Description:** Rate of incomplete colonoscopies due to inadequate preparation salvaged to adequate colonoscopies with the use of the Pure-Vu EVS System.

Inadequate OCs defined as such if any of the following are met:

* BBPS \< 6 (Adequacy is defined as BBPS of 2 or greater in each segment)
* Inability to identify \> 5mm polyps The estimated rate of salvaged preparations will be calculated and presented with exact one-sided 95% confidence interval: Number of preps inadequate with SOC and adequate after Pure-VU EVS System / Number of preps inadequate with SOC.

The lower bound will be compared to a 35% performance goal.

**Measure:** Rate of incomplete colonoscopies

**Time Frame:** Day 0 (Procedure Day)

#### Secondary Outcomes

**Description:** The following secondary endpoint will be assessed:

Number of polyps and adenomas: type, location, size, pathology and morphology

**Measure:** Assessment of Screening

**Time Frame:** Day 0 (Procedure Day)

**Description:** Boston Bowel Prep Score (BBPS) before and after Pure-Vu EVS use. Throughout the procedure, the study endoscopist will be requested to document the pre-cleansing BBPS and post- cleansing BBPS for each colon segment.

**Measure:** Assessment of Screening

**Time Frame:** Day 0 (Procedure Day)

**Description:** Sedation type The type of sedation will not be dictated by the study but will be documented.

**Measure:** Procedural Outcome

**Time Frame:** Day 0 (Procedure Day)

**Description:** Cecum Intubation Rate

**Measure:** Procedural Outcome

**Time Frame:** Day 0 (Procedure Day)

**Description:** Polyp Miss Rate (PMR)

**Measure:** Assessment screening

**Time Frame:** Day 0 (Procedure Day)

**Description:** Adenoma Detection Rate (ADR)

**Measure:** Assessment screening

**Time Frame:** Day 0 (Procedure Day)

**Description:** Adenoma Miss Rate (AMR)

**Measure:** Assessment screening

**Time Frame:** Day 0 (Procedure Day)

**Description:** Adenoma Per Colonoscopy (APC)

**Measure:** Assessment screening

**Time Frame:** Day 0 (Procedure Day)

**Description:** Adenomas Per Positive Patient (APP)

**Measure:** Assessment screening

**Time Frame:** Day 0 (Procedure Day)

**Description:** Sessile Serrated Adenoma Detection Rate

**Measure:** Assessment screening

**Time Frame:** Day 0 (Procedure Day)

**Description:** Polyp Detection Rate (PDR)

**Measure:** Assessment Screening

**Time Frame:** Day 0 (Procedure Day)

**Description:** Procedure Time: Time to cecum and withdrawal time

**Measure:** Procedural Outcomes

**Time Frame:** Day 0 (Procedure Day)

**Description:** Intraprocedural tools The type of Intraprocedural tools will not be dictated by the study but will be documented.

**Measure:** Procedural Outcomes

**Time Frame:** Day 0 (Procedure Day)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Eligible adults aged between 40-80
2. Elective outpatient colonoscopy by participating gastroenterologist

Exclusion Criteria:

1. Not competent to consent
2. Known or suspected bleeding disorders such as, but not limited to hemophilia and von Willebrand disease
3. History of colonic resection
4. Prior incomplete colonoscopy due to patient anatomy
5. Diverticulitis
6. Active Inflammatory bowel disease (Crohn's, Ulcerative Colitis, or Indeterminate)
7. Known or suspected colon stricture
8. Hereditary Colorectal Cancer Syndrome
9. Subject is pregnant or suspected pregnant

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New York

**Country:** United States

**Facility:** NYU

**State:** New York

**Zip:** 02241

#### Overall Officials

**Official 1:**

**Affiliation:** Motus GI Medical Technologies Ltd

**Name:** Mark Pomeranz

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Access Criteria:** clinicaltrials.gov

**Description:** Information regarding the study and study data will be made available via publication on clinicaltrials.gov.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- CSR

**IPD Sharing:** YES

**Time Frame:** Upon completion of the study.

**URL:** http://www.clinicaltrials.gov

### References Module

#### See Also Links

**Label:** More information about Pure-VU® EVS

**URL:** https://www.motusgi.com/physicians-nurses/pure-vu-system/

## Document Section

### Large Document Module

#### Large Docs

- Date: 2022-10-31

- Filename: Prot_001.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 972494

- Type Abbrev: Prot

- Upload Date: 2022-11-15T15:50

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
