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NCT02609100 · ClinicalTrials.gov registry record · NA
Video Capsule Endoscopy Versus Colonoscopy in Patients With Melena and Negative Upper Endoscopy
A NA study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT02609100: Clinical Trial NA study, sponsored by Washington University School of Medicine.
NCT02609100 is a NA study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02609100, a NA study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study Summary
Acute gastrointestinal bleeding is a common medical problem. When patients with gastrointestinal bleeding present with melena (dark, tarry stool) the blood loss is usually originating in the upper gastrointestinal tract (esophagus, stomach or duodenum) and first step in evaluating the patient is an upper endoscopy; which allows direct visualization of the esophagus, stomach and duodenum. However, the cause of bleeding is located in the small bowel or colon in 20-30% of patients who present with melena. Traditionally colonoscopy has been the next test preformed if upper endoscopy does not identify the cause of melena/ gastrointestinal bleeding, however less than 25% of patients who present with melena have bleeding originating in the colon, and the remainder of patients have bleeding originating in the small intestine, which can only be fully evaluated with video capsule endoscopy (a pill camera which is swallowed and takes pictures while it travels thought the small bowel and colon). Currently patients only undergo video capsule endoscopy if colonoscopy does not identify the cause of bleeding. The investigators are preforming a randomized study which seeks to determine if colonoscopy or video capsule endoscopy is a better way to identify the cause of gastrointestinal bleeding in patients who present with melena and have normal findings on upper endoscopy. To do this the investigators will enroll patients who present with melena prior to their upper endoscopy and if the cause of bleeding is not identified at that time patients will be randomized to video capsule endoscopy (with the capsule being placed into the small bowel during the upper endoscopy) or next day colonoscopy.
Primary Outcome
Video Capsule Endoscopy identifies clinically significant lesions defined as lesions considered to have high potential for bleeding, such as a large ulceration, tumor or typical angiomata
Interventions
- PROCEDURE Colonoscopy
- PROCEDURE Video Capsule Endoscopy
- DEVICE 1.0 X 2.5 cm 'pill' containing a camera
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2015-11 |
| Est. Completion | 2016-12-06 |
| Phase | NA |
Why NCT02609100 stopped before completion
NCT02609100 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 3 interventions - of which Colonoscopy is the first listed.
NCT02609100 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02609100 about?
NCT02609100 is a clinical study titled "Video Capsule Endoscopy Versus Colonoscopy in Patients With Melena and Negative Upper Endoscopy". Acute gastrointestinal bleeding is a common medical problem. When patients with gastrointestinal bleeding present with melena (dark, tarry stool) the blood loss is usually originating in the upper gastrointestinal tract (esophagus, stomach or duodenum) and first step in evaluating the patient is an ...
What is the current status of trial NCT02609100?
This trial is currently terminated. It is a NA study. The enrollment target is 4 participants. The study started on 2015-11. Estimated completion is 2016-12-06.
What interventions are being tested in trial NCT02609100?
The interventions under investigation include: Colonoscopy (PROCEDURE), Video Capsule Endoscopy (PROCEDURE), 1.0 X 2.5 cm 'pill' containing a camera (DEVICE).
Who is sponsoring clinical trial NCT02609100?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02609100's enrollment target sits among peer trials
4 1996th of 2000 higher than 5 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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