Demonstrating Effective Salvage of Inadequate Colonoscopies

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Colorectal Screening

Intervention / Treatment
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* Device: Pure-Vu EVS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible adults aged between 40-80 Elective outpatient colonoscopy by participating gastroenterologist Exclusion Criteria: Not competent to consent Known or suspected bleeding disorders such as, but not limited to hemophilia and von Willebrand disease History of colonic resection Prior incomplete colonoscopy due to patient anatomy Diverticulitis Active Inflammatory bowel disease (Crohn's, Ulcerative Colitis, or Indeterminate) Known or suspected colon stricture Hereditary Colorectal Cancer Syndrome Subject is pregnant or suspected pregnant

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Multicenter, Prospective, Consecutive Series, Pragmatic Clinical Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pure-Vu EVS<br>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. | Device: Pure-Vu EVS<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 0 (Procedure Day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Screening | The following secondary endpoint will be assessed: Number of polyps and adenomas: type, location, size, pathology and morphology | Day 0 (Procedure Day) | 
| Assessment of Screening | 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. | Day 0 (Procedure Day) | 
| Procedural Outcome | Sedation type The type of sedation will not be dictated by the study but will be documented. | Day 0 (Procedure Day) | 
| Procedural Outcome | Cecum Intubation Rate | Day 0 (Procedure Day) | 
| Assessment screening | Polyp Miss Rate (PMR) | Day 0 (Procedure Day) | 
| Assessment screening | Adenoma Detection Rate (ADR) | Day 0 (Procedure Day) | 
| Assessment screening | Adenoma Miss Rate (AMR) | Day 0 (Procedure Day) | 
| Assessment screening | Adenoma Per Colonoscopy (APC) | Day 0 (Procedure Day) | 
| Assessment screening | Adenomas Per Positive Patient (APP) | Day 0 (Procedure Day) | 
| Assessment screening | Sessile Serrated Adenoma Detection Rate | Day 0 (Procedure Day) | 
| Assessment Screening | Polyp Detection Rate (PDR) | Day 0 (Procedure Day) | 
| Procedural Outcomes | Procedure Time: Time to cecum and withdrawal time | Day 0 (Procedure Day) | 
| Procedural Outcomes | Intraprocedural tools The type of Intraprocedural tools will not be dictated by the study but will be documented. | Day 0 (Procedure Day) |