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NCT01607255 · ClinicalTrials.gov registry record · Phase 4
Comparative Efficacy of Water & Indigo Carmine vs. Water or Air Method on Adenoma Detection Rate (ADR) - a Randomized Controlled Trial (RCT)
A Phase 4 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 4
- Development phase
- 480
- Enrollment target
NCT01607255: Completed Phase 4 study, sponsored by VA Office of Research and Development.
NCT01607255 is a Phase 4 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 480 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01607255, a Phase 4 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 480 participants
- Enrollment target
Study Summary
Adenoma detection rate (ADR) is a quality indicator of colonoscopy performed for colorectal cancer screening. Population studies have shown that traditional air colonoscopy fails to eliminate post screening colonoscopy cancers or cancer mortality in the proximal colon. The investigators aim to establish the superior effectiveness of combining chromoendoscopy with the water exchange method in detecting more proximal diminutive adenomas during screening colonoscopy in sedated Veterans. An improved adenoma detection rate associated with optical colonoscopy will minimize the risk of missed lesions. The improvement may translate into a remedy for the limitations of screening colonoscopy in the proximal colon, e.g. a higher adenoma detection rate may minimize the burden of post screening colonoscopy interval colorectal cancers among the veteran population.
Primary Outcome
Proximal diminutive adenoma detection rate (ADR) in screening colonoscopy performed with the unusual air method, versus the water (exchange) method and with dye added to the water (exchange) method
Interventions
- DRUG Indigo carmine
- PROCEDURE water (exchange) method
- PROCEDURE water (exchange) plus dye method
- PROCEDURE air method
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 480 participants |
| Start Date | 2013-05-16 |
| Est. Completion | 2017-09-30 |
| Phase | Phase 4 |
What the finished NCT01607255 record still lists
NCT01607255 is an interventional study that assigns participants to a tested intervention. The registered 480 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Indigo carmine is the first listed.
NCT01607255 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01607255 about?
NCT01607255 is a clinical study titled "Comparative Efficacy of Water & Indigo Carmine vs. Water or Air Method on Adenoma Detection Rate (ADR) - a Randomized Controlled Trial (RCT)". Adenoma detection rate (ADR) is a quality indicator of colonoscopy performed for colorectal cancer screening. Population studies have shown that traditional air colonoscopy fails to eliminate post screening colonoscopy cancers or cancer mortality in the proximal colon. The investigators aim to estab...
What is the current status of trial NCT01607255?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 480 participants. The study started on 2013-05-16. Estimated completion is 2017-09-30.
What interventions are being tested in trial NCT01607255?
The interventions under investigation include: Indigo carmine (DRUG), water (exchange) method (PROCEDURE), water (exchange) plus dye method (PROCEDURE), air method (PROCEDURE).
Who is sponsoring clinical trial NCT01607255?
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 NCT01607255's enrollment target sits among peer trials
480 182nd of 2000 higher than 1,819 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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