Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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. 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01607255
The ClinicalTrials.gov registry entry for NCT01607255 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 480 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Indigo carmine is the first listed.
NCT01607255 reports 0 study locations.
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
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.