Demonstrating Effective Salvage of Inadequate Colonoscopies

Motus GI Medical Technologies Ltd16 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Colorectal Screening

Interventions

Pure-Vu EVSDEVICE

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

NYU

New York, New York, United States

Outcomes

Primary Outcomes

Rate of incomplete colonoscopies

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.