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NCT03955055 · ClinicalTrials.gov registry record · NA
Study of Early Endocapsule (EC) in Clinical Decision Unit Versus Standard of Care Work-up for GI Bleeding
A NA study of GastroIntestinal Bleeding and Hematemesis, sponsored by Christopher Marshall.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT03955055: Completed NA study of GastroIntestinal Bleeding and Hematemesis, sponsored by Christopher Marshall.
NCT03955055 is a NA study of GastroIntestinal Bleeding and Hematemesis that has completed, run by Christopher Marshall. The registered enrollment target is 35 participants, below the 3,291-participant average among 4 other GastroIntestinal Bleeding trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03955055, a NA study of GastroIntestinal Bleeding and Hematemesis, has completed, sponsored by Christopher Marshall.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the use of the Olympus EndoCapsule EC-10 video capsule compared with the standard of care workup for patients in the Clinical Decision Unit who have symptoms of gastrointestinal (GI) bleeding. Patients will be eligible if they have any symptoms of GI bleeding, either vomiting blood or symptoms without vomiting blood. Patients randomized to the early capsule arm will have an immediate video capsule endoscopy. Patients randomized to the standard of care arm will have no study intervention and will follow the treating physician's diagnostic workup. The primary goal of the study is to compare how often a source of bleeding is identified in patients in the two groups.
Primary Outcome
Rate of detection of active bleeding or stigmata of recent bleeding \[blood clot or visible vessel\]
Conditions Studied
Interventions
- DEVICE Video Capsule Endoscopy
Study Locations (1)
Massachusetts
- UMass Memorial Medical Center - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2020-02-04 |
| Est. Completion | 2022-04-09 |
| Phase | NA |
What the finished NCT03955055 record still lists
NCT03955055 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 3,291-participant average among 4 other GastroIntestinal Bleeding trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with GastroIntestinal Bleeding appearing as the primary indexed condition, and to 1 intervention - of which Video Capsule Endoscopy is the first listed.
NCT03955055 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03955055 about?
NCT03955055 is a clinical study titled "Study of Early Endocapsule (EC) in Clinical Decision Unit Versus Standard of Care Work-up for GI Bleeding". This study will evaluate the use of the Olympus EndoCapsule EC-10 video capsule compared with the standard of care workup for patients in the Clinical Decision Unit who have symptoms of gastrointestinal (GI) bleeding. Patients will be eligible if they have any symptoms of GI bleeding, either vomitin...
What is the current status of trial NCT03955055?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2020-02-04. Estimated completion is 2022-04-09.
What conditions does trial NCT03955055 study?
This clinical trial studies the following conditions: GastroIntestinal Bleeding, Hematemesis, Melena.
What interventions are being tested in trial NCT03955055?
The interventions under investigation include: Video Capsule Endoscopy (DEVICE).
Who is sponsoring clinical trial NCT03955055?
This trial is sponsored by Christopher Marshall, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03955055 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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