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NCT03160859 · ClinicalTrials.gov registry record · NA
Prospective RCT Of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 280
- Enrollment target
NCT03160859: Completed NA study, sponsored by VA Office of Research and Development.
NCT03160859 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 280 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03160859, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 280 participants
- Enrollment target
Study Summary
This is a study to compare two different, but normally, used methods of colonoscopy in patients undergoing colonoscopy without sedation. There will be two arms in this study: WE (water exchange) control, and WE (water exchange) plus cap (placed at tip of the colonoscope). The patient will prepare himself/herself for the colonoscopy as per normal instructions and he/she will be given the information for the study at that time so that he/she can make a decision to participate in the study. The control method will use water instead of air during insertion of the colonoscope. The study method will use a cap that will fit onto the end of the colonoscope plus water during insertion of the colonoscope. This study will assess if the study method is less painful than the control method.
Primary Outcome
Pain during insertion reported to the unblinded assisting nurse, visual analogue scale, VAS: 0=none, 10=most severe. The highest pain score will be tabulated for analysis. Timing of data collection will be at the discretion of the nurse to minimize bias by colonoscopist behavior.
Interventions
- OTHER Control
- DEVICE Study method
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2018-06-08 |
| Est. Completion | 2022-10-28 |
| Phase | NA |
What the finished NCT03160859 record still lists
NCT03160859 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT03160859 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03160859 about?
NCT03160859 is a clinical study titled "Prospective RCT Of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy". This is a study to compare two different, but normally, used methods of colonoscopy in patients undergoing colonoscopy without sedation. There will be two arms in this study: WE (water exchange) control, and WE (water exchange) plus cap (placed at tip of the colonoscope). The patient will prepare hi...
What is the current status of trial NCT03160859?
This trial is currently completed. It is a NA study. The enrollment target is 280 participants. The study started on 2018-06-08. Estimated completion is 2022-10-28.
What interventions are being tested in trial NCT03160859?
The interventions under investigation include: Control (OTHER), Study method (DEVICE).
Who is sponsoring clinical trial NCT03160859?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03160859's enrollment target sits among peer trials
280 380th of 2000 higher than 1,620 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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