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RECRUITING
NCT03616041

Capsule Endoscopy for Severe Hematochezia

Sponsor: CURE Digestive Diseases Research Center

View on ClinicalTrials.gov

Summary

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.

Official title: Video Capsule Endoscopy for Lesion Localization and Diagnosis in Patients With Severe Hematochezia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

23

Start Date

2021-02-10

Completion Date

2024-12-31

Last Updated

2024-08-12

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

Second-generation colon capsule endoscopy system

The 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.

Locations (2)

VA Greater Los Angeles Healthcare System

Los Angeles, California, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States