Demonstrating Effective Salvage of Inadequate Colonoscopies

Motus GI

Status: Terminated

Conditions: Colorectal Screening

Treatments: Device: Pure-Vu EVS

Study type: Interventional

Funder types: Industry

Identifiers

NCT05585879

CL00052

Details and patient eligibility

About

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.

Full 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).

Enrollment: 16 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Pure-Vu EVS

Other group

Description:

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.

Treatment:

Device: Pure-Vu EVS