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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
Male and female 50-75 yrs of age.
Positive screening for Fecal Immunochemical Test (FIT) or Fecal Occult Blood Test (FOBT).
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 Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

ASGE Trial Timeline

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

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 more

ASGE 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
1,528 Previous Clinical Trials
10,275,221 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
6,939 Total Patients Enrolled
Felix W Leung, MDPrincipal InvestigatorVA Greater Los Angeles Healthcare System
3 Previous Clinical Trials
345 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the minimum age requirement for this trial 18 years and above?

"This clinical trial is welcoming those with ages between 50 and 75 years of age."

Answered by AI

What is the upper limit of participants that can take part in this investigation?

"Affirmative. Clinicaltrials.gov reveals that this medical trial is still actively seeking participants, with the first post going up on July 1st 2018 and a recent update taking place on October 4th 2022. 1630 individuals are being sought from 2 separate locations for enrollment in the study."

Answered by AI

Who meets the criteria to partake in this investigation?

"Eligibility criteria for this trial necessitates that potential participants have had a colonoscopy and be aged 50 to 75. The investigators are hoping to recruit 1630 individuals in total."

Answered by AI

Is the window still open for enrollment in this research project?

"Indeed, the clinicaltrials.gov database shows that this trial is actively recruiting and has been since July 1st 2018. The study seeks to enrol 1630 patients from 2 different medical centres."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Veterans Affairs Palo Alto Healthcare System
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Does the Cap Increase the Finding of Polyps When Water Exchange Colonoscopy is Used
Felix W. Leung 2018. "Does the Cap Increase the Finding of Polyps When Water Exchange Colonoscopy is Used". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03566615.
~241 spots leftby Apr 2025
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