Demonstrating Effective Salvage of Inadequate Colonoscopies

Not Applicable

Terminated

• Conditions: Colorectal Screening
• Interventions: Device: Pure-Vu EVS

• Registration Number: NCT05585879
• Lead Sponsor: Motus GI Medical Technologies Ltd

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).

Study Timeline

• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-10-14
• Study First Posted: 2022-10-19
• Study Start: 2022-11-03
• Primary Completion: 2024-04-26
• Study Completion: 2024-04-26
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pure-Vu EVS	Pure-Vu EVS	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.

Primary Outcome Measures

Name	Time	Method
Rate of incomplete colonoscopies	Day 0 (Procedure Day)	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.

Secondary Outcome Measures

Name	Time	Method
Assessment screening	Day 0 (Procedure Day)	Sessile Serrated Adenoma Detection Rate
Procedural Outcomes	Day 0 (Procedure Day)	Intraprocedural tools The type of Intraprocedural tools will not be dictated by the study but will be documented.
Assessment Screening	Day 0 (Procedure Day)	Polyp Detection Rate (PDR)
Assessment of Screening	Day 0 (Procedure Day)	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.
Procedural Outcome	Day 0 (Procedure Day)	Cecum Intubation Rate

Trial Locations

Locations (1)

NYU; 🇺🇸 New York, New York, United States