Your session is about to expire
← Back to Search
Procedure
Cap-Assisted Colonoscopy for Reduced Pain and Insertion Time (VA 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 hours
Awards & highlights
VA Trial Summary
This trial is testing whether the addition of a cap to a water exchange method during colonoscopy is less painful and results in shorter insertion time than the water exchange method alone.
Who is the study for?
This trial is for male and female Veterans who opt for unsedated colonoscopy, whether it's for screening, diagnosis, or surveillance. Participants must be able to consent and complete questionnaires. Those with a history of certain abdominal surgeries, current heavy medication use, or conditions that complicate colonoscopy are excluded.Check my eligibility
What is being tested?
The study compares two methods during a colonoscopy: the Water Exchange (WE) method alone versus WE plus Cap-assisted Colonoscopy (WECAC). The goal is to see if adding a cap reduces pain more than WE alone and if it improves the procedure time and detection rate of adenomas in the proximal colon.See study design
What are the potential side effects?
While not explicitly listed in your information provided, typical side effects from these procedures may include discomfort or mild pain due to gas insufflation, bloating, cramping sensations during insertion of the scope or when using water exchange techniques.
VA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Real-time maximum insertion pain(RTMIP) score
Secondary outcome measures
Insertion time
Proportion with no insertion pain
Proximal colon ADR
VA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: WE plus cap(WECAC)Experimental Treatment2 Interventions
The procedure of this group is similar with WE group, except a cap will be fitted onto the end of the colonoscope.
Group II: Water exchange (WE)Active Control1 Intervention
This group will have the air in the colon removed and replaced with water to guide the insertion of the colonoscope.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cap
2017
N/A
~710
Find a Location
Who is running the clinical trial?
VA Greater Los Angeles Healthcare SystemLead Sponsor
51 Previous Clinical Trials
8,313 Total Patients Enrolled
VA Palo Alto Health Care SystemFED
87 Previous Clinical Trials
56,607 Total Patients Enrolled
VA Northern California Health Care SystemFED
18 Previous Clinical Trials
3,191 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an artificial heart valve.You have a medical condition that could make colonoscopy risky for you.You have a medical condition that won't allow you to benefit from colonoscopy screening.You have a history of ongoing inflammation in your intestines.You have had bleeding in your intestines or rectum in the past.You have had a colonoscopy as part of a medical treatment.You will not be able to undergo a procedure called bidirectional endoscopy.You have a history of severe diverticulosis or diverticulitis.You are currently taking prescription medicine for pain or anxiety.You have previously had a colonoscopy without sedation, and it was not successful.You are currently taking medication to prevent blood clots.You do not have any non-medical issues that could interfere with your participation in the study.
Research Study Groups:
This trial has the following groups:- Group 1: WE plus cap(WECAC)
- Group 2: Water exchange (WE)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the eligibility criteria for this trial extend to those younger than sixty years old?
"Guided by the trial's eligibility requirements, only individuals aged 18 or over and under 80 are qualified to participate."
Answered by AI
What is the cap on participant numbers for this investigation?
"Affirmative. According to clinicaltrials.gov data, this medical study is currently accepting participants for recruitment. Initially posted on the 21st of May 2018 and last edited on the 31st of January 2022, 256 individuals are being sought from two different research sites."
Answered by AI
Do I meet the criteria to join this research effort?
"Applicants to this medical trial must have had a recent colonoscopy and meet the age criteria of between 18-80. Altogether, 256 participants need to be recruited."
Answered by AI
Is enrollment for this experiment still available to participants?
"Correct. The information present on clinicaltrials.gov attests that this experiment, which had its initial posting on May 21st 2018, is currently recruiting participants. A total of 256 individuals are needed to be enrolled between two research facilities."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger