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NCT03952611 · ClinicalTrials.gov registry record · NA
Three Arm Rand Trial of HD Light vs Reveal® Cap vs Endocuff Cap for Detection of Colorectal Adenomas (TRACE)
A NA study, sponsored by Midwest Biomedical Research Foundation.
- Completed
- Registry status
- NA
- Development phase
- 1,203
- Enrollment target
NCT03952611 is a NA study that has completed, run by Midwest Biomedical Research Foundation. The registered enrollment target is 1,203 participants.
The verdict
NCT03952611, a NA study, has completed, sponsored by Midwest Biomedical Research Foundation.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,203 participants
- Enrollment target
Study Summary
Protocol Title: Three Arm Prospective Randomized controlled trial of High-Definition White-light colonoscopy versus High-Definition White-light colonoscopy with Reveal® Distal Attachment Cap versus High-Definition White-light colonoscopy with Endocuff Vision for the detection of colorectal adenomas Hypothesis: Detection rate of adenomas in patients will be higher in procedures performed with High-Definition White-light (HDWL) colonoscopy with Reveal® distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopes alone Design: Multicenter, Prospective, randomized controlled study Primary Aim: To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision. Secondary Aims: To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision. To compare the detection rates for polyp subtypes (including advanced adenomas, serrated polyps, right sided adenomas, etc.), cecal intubation rate, insertion time, withdrawal time, and complications of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Interventions
- PROCEDURE Colonoscopy
- DEVICE distal Cap
- DEVICE Endocuff
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,203 participants |
| Start Date | 2018-03-16 |
| Est. Completion | 2022-06-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03952611
The ClinicalTrials.gov registry entry for NCT03952611 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,203 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Midwest Biomedical Research Foundation, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Colonoscopy is the first listed.
NCT03952611 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03952611 about?
NCT03952611 is a clinical study titled "Three Arm Rand Trial of HD Light vs Reveal® Cap vs Endocuff Cap for Detection of Colorectal Adenomas (TRACE)". Protocol Title: Three Arm Prospective Randomized controlled trial of High-Definition White-light colonoscopy versus High-Definition White-light colonoscopy with Reveal® Distal Attachment Cap versus High-Definition White-light colonoscopy with Endocuff Vision for the detection of colorectal adenomas ...
What is the current status of trial NCT03952611?
This trial is currently completed. It is a NA study. The enrollment target is 1,203 participants. The study started on 2018-03-16. Estimated completion is 2022-06-10.
What interventions are being tested in trial NCT03952611?
The interventions under investigation include: Colonoscopy (PROCEDURE), distal Cap (DEVICE), Endocuff (DEVICE).
Who is sponsoring clinical trial NCT03952611?
This trial is sponsored by Midwest Biomedical Research Foundation, which has 13 total clinical trials registered on ClinicalTrials.gov.
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