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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 18 years old or older

• Able to provide written informed consent or have a legal surrogate who can provide written consent

• Presenting with evidence of severe ongoing hematochezia (i.e. passage of red blood or clots per rectum witnessed by a health care provider) and have a decrease in hemoglobin from baseline of 2 or more grams and/or transfusion of 1 or more units of red blood cells for resuscitation with either outpatient or inpatient start of severe hematochezia.

Locations
United States
California
Ronald Reagan UCLA Medical Center
NOT_YET_RECRUITING
Los Angeles
VA Greater Los Angeles Healthcare System
RECRUITING
Los Angeles
Time Frame
Start Date: 2021-02-10
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 23
Treatments
Colon capsule endoscopy
Participant 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.
Related Therapeutic Areas
Sponsors
Leads: CURE Digestive Diseases Research Center

This content was sourced from clinicaltrials.gov