CAP-straight for Colon Polyps (ASGE Trial)

N/A

Waitlist Available

Led By Felix W Leung, MD

Research Sponsored by VA Greater Los Angeles Healthcare System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial compares three methods of performing a colonoscopy to see which is best at finding polyps. It involves patients who need regular colonoscopies. The methods use water to guide the scope, with two methods adding a small cap to improve visibility.

Eligible Conditions

Colon Polyps
Colonoscopy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adenoma detection rate

Secondary study objectives

Boston bowel preparation score

Cecal intubation

Cecal intubation time

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: CAP-straightExperimental Treatment2 Interventions

A straight transparent cap was fitted to the colonoscope per manufacturer instruction.Residual air in the colon will be removed, water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion.

Group II: CAP-daisyExperimental Treatment2 Interventions

A daisy cap transparent cap was fitted to the colonoscope per manufacturer instruction.Residual air in the colon will be removed, water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion. Note: IRB Approval date for the use of Endocuff at St. Barbara Hospital, Iglesias (CA), Italy, was obtained on 3/8/2017. IRB Approval date for the use of Endocuff at Evergreen General Hospital, Taipei, Taiwan, was obtained on 3/18/2021.

Group III: WaterActive Control1 Intervention

Residual air in the colon will be removed, water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion.

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