## Protocol Section
### Identification Module
**NCT ID:** NCT06422312

**Brief Title:** A Study Comparing a Disposable Flexible Cystoscope With Reusable Scopes in Adult Patients.

**Official Title:** Clinical Investigation to Evaluate the Effectiveness of the Redpine Disposable Scope Compared to Standard Reusable Scope for Flexible Cystoscopy.

#### Organization Study ID Info
**ID:** USA001
#### Organization
**Class:** INDUSTRY
**Full Name:** Guangzhou Red Pine Medical Instrument Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

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

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Texas Southwestern Medical Center

**Class:** OTHER

**Name:** University of Washington

**Class:** OTHER

**Name:** Penn State University

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Guangzhou Red Pine Medical Instrument Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study will compare the time required for a cystoscopy procedure in adult participants using the Redpine® Rflex endo(trademark) High-Definition Cystoscope or the site's standard of care reusable flexible cystoscope in participants requiring urethral stent removal.

**Detailed Description:** This randomized study will compare the cumulative procedure time between cystoscopy performed with the Redpine® Rflex endo(trademark) High-Definition Cystoscope and the site's standard of care reusable flexible cystoscope in adult study participants requiring cystoscopy for visualization of and/or intervention on the urinary bladder. The study will evaluate the user experience and product performance during cystoscopic procedures. Participant experience, tolerance to the procedure, and any differences in adverse events between disposable and reusable scope will be evaluated. The hypothesis is that the RedPine cystoscope will perform as well as reusable scopes and will have a shorter cumulative procedure time.

### Conditions Module

**Conditions:**

- Bladder Cancer

- Bladder Stone

- Bladder Outlet Obstruction

- Renal Stone

- Renal Disease

**Keywords:**

- cystoscopy

- urinary stint removal

- bladder biopsy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 140

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants in this arm will receive cystoscopy using the clinic's standard of care flexible reusable cystoscope of the urologist's choice.

**Intervention Names:**

- Device: Cystoscopy with RedPine flexible disposable cystoscope

**Label:** Control

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Participants in this arm will receive cystoscopy using the Redpine® Rflex endoTMHD Cysto scope.

**Intervention Names:**

- Device: Cystoscopy with RedPine flexible disposable cystoscope

**Label:** Intervention

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control

- Intervention

**Description:** Use of a flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents.

**Name:** Cystoscopy with RedPine flexible disposable cystoscope

**Other Names:**

- Cystoscopy with standard of care flexible reusable scope

**Type:** DEVICE

### Outcomes Module

#### Other Outcomes

**Description:** Safety will be assessed based on the incidence rates of adverse events based on the seriousness and relatedness to the device and/or procedure.

1. All urologic adverse events, both device and procedure related, during the cystoscopy procedure through 7 (+/- 3) days post-procedure.
2. All reported device and/or procedural related adverse events through 7 (+/- 3) days post- procedure
3. All Serious Adverse Events (SAEs) through 7 (+/- 3) days post-procedure

**Measure:** Safety Endpoints

**Time Frame:** 4 to 10 days

#### Primary Outcomes

**Description:** To compare the Cumulative Procedure Time between cystoscopy performed with the Redpine® Rflex endo(trademark) High Definition (endoTMHD) Cysto scope and the site's Standard of Care reusable flexible cystoscope as measured by:

* Scope preparation for procedure
* Actual procedure time (insertion of cystoscope to complete bladder examination) and
* Time to dispose of or prepare for reprocessing of cystoscopy equipment.

**Measure:** Cumulative Procedure Time

**Time Frame:** 30 minutes

#### Secondary Outcomes

**Description:** Physician satisfaction, rated on a five-point scale. i) Ease of insertion ii) Ability to visualize anatomical landmarks and/or urothelium changes iii) Perception of image quality iv) Maneuverability in the bladder v) Scope articulation with tools in the working channel vi) Visualization while tools are in the working channel

**Measure:** User experience and product performance during cystoscopic procedures

**Time Frame:** within 24 hours

**Description:** Participants will be interviewed using a questionnaire.

**Measure:** Participant comfort during the procedure

**Time Frame:** 30 minutes

**Description:** Rate of conversion to a reusable cystoscope for those subjects randomized to the REDPINE cystoscope.

**Measure:** RedPine Cystoscope Conversion Rate

**Time Frame:** 30 minutes

**Description:** Device failure leading to a serious adverse event (SAE), termination of the procedure, or conversion to a reusable cystoscope.

**Measure:** Device Failure Rate

**Time Frame:** 30 minutes

**Description:** Device malfunction including any device-related issue or observation whether it leads to an SAE, termination of the procedure or conversion to a reusable cystoscope.

**Measure:** Device Malfunction Rate

**Time Frame:** 30 minutes

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Male or female, aged at least 18 years old
2. Patient undergoing routine flexible cystoscopy
3. No active urinary tract infection
4. Subject is willing and able to sign informed consent and HIPAA authorization.

Exclusion Criteria:

1. Known unpassable urethral stricture
2. Febrile patient with active urinary tract infection (UTI)
3. Subjects with acute infection (acute urethritis, acute prostatitis, acute epididymitis)
4. Subject with severe coagulopathy
5. Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control.

**Maximum Age:** 120 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Gregl@uroessentials.com

**Name:** Greg Lips

**Phone:** 800-570-4962

**Role:** CONTACT

**Contact 2:**

**Email:** dan_laferriere@msn.com

**Name:** Daniel S Laferriere, MS

**Phone:** 5037586788

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hershey

**Contacts:**

***Contact 1:***

- **Email:** UrologyResearch@pennstatehealth.psu.edu

- **Name:** Suzanne L Boltz, B.S.

- **Phone:** 717-531-0003

- **Phone Ext:** 287502

- **Role:** CONTACT

***Contact 2:***

- **Email:** UrologyResearch@pennstatehealth.psu.edu

- **Name:** Amogh Pande, M.S.

- **Phone:** 717-531-5930

- **Role:** CONTACT

**Country:** United States

**Facility:** Pennsylvania State University

**State:** Pennsylvania

**Zip:** 17033

**Location 2:**

**City:** Dallas

**Contacts:**

***Contact 1:***

- **Email:** brett.johnson@utsouthwestern.edu

- **Name:** Brett Johnson, MD

- **Phone:** 214-645-8765

- **Role:** CONTACT

***Contact 2:***

- **Email:** Sonobia.Garrett@UTSouthwestern.edu

- **Name:** Sonobia Garrett, BS

- **Phone:** 214-645-8482

- **Role:** CONTACT

***Contact 3:***

- **Name:** Brett Johnson, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** UT Southwestern Medical Center

**State:** Texas

**Zip:** 75390

#### Overall Officials

**Official 1:**

**Affiliation:** UT Southwestern Medical Center

**Name:** Yair Lotan, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Samplaski MK, Jones JS. Two centuries of cystoscopy: the development of imaging, instrumentation and synergistic technologies. BJU Int. 2009 Jan;103(2):154-8. doi: 10.1111/j.1464-410X.2008.08244.x. Epub 2008 Dec 8.

**PMID:** 19076146

**Citation:** O'Sullivan DC, Chilton CP. Flexible cystoscopy. Br J Hosp Med. 1994 Apr 6-19;51(7):340-5.

**PMID:** 8081563

**Citation:** Poulton LJ, Joyce AD. Flexible cystoscopy: Training and Assessment Guideline. Br Assoc Urol Nurses. 2012;(November).

**Citation:** Pillai PL, Sooriakumaran P. Flexible cystoscopy: a revolution in urological practice. Br J Hosp Med (Lond). 2009 Oct;70(10):583-5. doi: 10.12968/hmed.2009.70.10.44626.

**PMID:** 19966704

**Citation:** Kadi N, Menezes P. ABC of flexible cystoscopy for junior trainee and general practitioner. Int J Gen Med. 2011;4:593-6. doi: 10.2147/IJGM.S20267. Epub 2011 Aug 19.

**PMID:** 21887113

**Citation:** Steinberg. Cystoscopy in Bladder Carcinoma [Internet]. Medscape. 2015 [cited 2018 Jan 18]. Available from: https://emedicine.medscape.com/article/1950345-overview

**Citation:** Doizi S, Kamphuis G, Giusti G, Palmero JL, Patterson JM, Proietti S, Straub M, de la Rosette J, Traxer O. First clinical evaluation of a new single-use flexible cystoscope dedicated to double-J stent removal (Isiris): a European prospective multicenter study. World J Urol. 2017 Aug;35(8):1269-1275. doi: 10.1007/s00345-016-1986-0. Epub 2016 Dec 17.

**PMID:** 27988848

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000001745

- Term: Urinary Bladder Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000002137

- Term: Calculi

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000052878

- Term: Urolithiasis

- ID: D000014545

- Term: Urinary Calculi

- ID: D000014524

- Term: Urethral Obstruction

- ID: D000014522

- Term: Urethral Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC04

- Name: Neoplasms

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10693

- Name: Kidney Calculi

- Relevance: LOW

- As Found: Unknown

- ID: M27126

- Name: Nephrolithiasis

- Relevance: LOW

- As Found: Unknown

- ID: M5399

- Name: Calculi

- Relevance: LOW

- As Found: Unknown

- ID: M5030

- Name: Urinary Bladder Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5029

- Name: Urinary Bladder Neck Obstruction

- Relevance: HIGH

- As Found: Bladder Outlet Obstruction

- ID: M5025

- Name: Urinary Bladder Calculi

- Relevance: HIGH

- As Found: Bladder Stone

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M5026

- Name: Urinary Bladder Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M27103

- Name: Urolithiasis

- Relevance: LOW

- As Found: Unknown

- ID: M17295

- Name: Urinary Calculi

- Relevance: LOW

- As Found: Unknown

- ID: M17274

- Name: Urethral Obstruction

- Relevance: LOW

- As Found: Unknown

- ID: M17272

- Name: Urethral Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001748

- Term: Urinary Bladder Neck Obstruction

- ID: D000001744

- Term: Urinary Bladder Calculi

### Misc Info Module

- Version Holder: 2024-05-31
