Capsule Endoscopy for Severe Hematochezia
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- CURE Digestive Diseases Research Center
- Study ID
- NCT03616041
- Status
- Recruiting
Conditions
- Hematochezia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Second-generation colon capsule endoscopy system — DEVICEThe PillCam (TM) Colon 2 which is a second-generation colon capsule endoscopy system, developed by Medtronic Inc. Colon capsule endoscopy, in contrast to current generation small bowel capsules, is capable of visualizing the entire lumen and mucosa from esophagus to rectum. This can be crucial for patients being screened or evaluated for colon disorders. This new generation of colon capsule endoscopy has a battery life of at least 10 hours and preserves energy using adaptive frame rate technology.
Study Details
Patients with severe hematochezia (bright red blood per rectum) may have a bleeding source proximal to the colon. Visualization of the entire gastrointestinal tract using a second-generation colon capsule endoscopy system could improve diagnostic yields and form the basis for a new approach to early diagnosis that could change guidelines and practice management in these patients. The hypothesis of this study is that urgent colon capsule endoscopy will have higher rates of lesion localization and diagnosis and reduced time to diagnosis than the standard tagged red blood cell scanning and/or angiography. In this study, the eligible patients with severe hematochezia are enrolled to undergo an evaluation with the capsule endoscopy in addition to the standard tests including a tagged RBC scan and/or an angiogram. The outcomes in terms of diagnostic yields of the capsule endoscopy will be compared to the standard tests.
Key Dates
- Start date
- Feb 10, 2021
- Status verified
- Aug 2024
- Primary completion
- Oct 30, 2024
- Completion
- Dec 31, 2024
Study Design
- Enrollment
- 23 participants (estimated)
Arms
- Arm: Colon capsule endoscopyParticipant who meet the eligible criteria undergo an evaluation for severe hematochezia with a second-generation colon capsule endoscopy system in addition to standard diagnostic tests including tagged RBC scan, and/or computerized tomographic angiography (CTA), and/or conventional angiography.
Primary Outcome Measure
The diagnostic yield tests in detecting a bleeding site and comparison of rates [ Time Frame: 30 days ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | |
| VA Greater Los Angeles Healthcare System | Los Angeles | California | 90073 | Dennis M Jensen, MD (PRINCIPAL_INVESTIGATOR) |