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Capsule Endoscopy for Severe Hematochezia

NCT03616041 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 23

Last updated 2024-08-12

No results posted yet for this study

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.

Conditions

  • Hematochezia

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.

Sponsors & Collaborators

  • CURE Digestive Diseases Research Center

    lead OTHER

Principal Investigators

  • Dennis M. Jensen, MD · VA Greater Los Angeles Healthcare System

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-10
Primary Completion
2024-10-30
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03616041 on ClinicalTrials.gov