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Control Method for Unsedated Colonoscopy

N/A
Waitlist Available
Led By Felix W. Leung, MD
Research Sponsored by VA Office of Research and Development
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 insertion time in minutes was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
Awards & highlights

Study Summary

This trial is testing whether a colonoscopy with a water-filled cap is less painful than a standard colonoscopy.

Eligible Conditions
  • Unsedated Colonoscopy
  • Colonoscopy
  • Capsule
  • Colonoscopy Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
This trial's timeline: 3 weeks for screening, Varies for treatment, and pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour for reporting.

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
Secondary outcome measures
Insertion Time
Proportion of Patients With No Insertion Pain
Right Colon Adenoma Detection Rate (ADR)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Study MethodExperimental Treatment1 Intervention
The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.
Group II: Control MethodExperimental Treatment1 Intervention
One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed predominantly during insertion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Study method
2018
N/A
~280

Find a Location

Who is running the clinical trial?

VA Palo Alto Health Care SystemFED
87 Previous Clinical Trials
56,583 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,004 Total Patients Enrolled
VA Northern California Health Care SystemFED
18 Previous Clinical Trials
3,167 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
American Journal of GastroenterologyJournal
A Patient-blinded Randomized, Controlled Trial Comparing Air Insufflation, Water Immersion, and Water Exchange During Minimally Sedated Colonoscopy
Hsieh, Yu-Hsi, Malcolm Koo, and Felix W Leung. 2014. “A Patient-blinded Randomized, Controlled Trial Comparing Air Insufflation, Water Immersion, and Water Exchange During Minimally Sedated Colonoscopy”. American Journal of Gastroenterology. Ovid Technologies (Wolters Kluwer Health). doi:10.1038/ajg.2014.126.
clinicaltrials.govStudy
Prospective RCT Of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy
2018. "Prospective RCT Of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03160859.
~41 spots leftby Apr 2025
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