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Procedure
CAP-straight for Colon Polyps (ASGE Trial)
N/A
Recruiting
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
ASGE Trial Summary
This trial is comparing two ways of doing a colonoscopy - the standard way using air, and a new way using water. They want to see if the new way is better at finding polyps and cancer.
Eligible Conditions
- Colon Polyps
- Colonoscopy
ASGE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adenoma detection rate
Secondary outcome measures
Boston bowel preparation score
Cecal intubation
Cecal intubation time
+2 moreASGE 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.
Find a Location
Who is running the clinical trial?
University of California, Los AngelesOTHER
1,538 Previous Clinical Trials
10,265,401 Total Patients Enrolled
1 Trials studying Colon Polyps
500 Patients Enrolled for Colon Polyps
VA Greater Los Angeles Healthcare SystemLead Sponsor
51 Previous Clinical Trials
6,937 Total Patients Enrolled
Felix W Leung, MDPrincipal InvestigatorVA Greater Los Angeles Healthcare System
3 Previous Clinical Trials
345 Total Patients Enrolled
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