Demonstrating Effective Salvage of Inadequate Colonoscopies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-03

Study Completion Date

2024-04-26

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.

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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).

Conditions

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Colorectal Screening

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Multicenter, Prospective, Consecutive Series, Pragmatic Clinical Trial

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Pure-Vu EVS

Intervention Type DEVICE

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

Interventions

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Pure-Vu EVS

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes