Actively Recruiting
Capsule Endoscopy for Severe Hematochezia
Led by CURE Digestive Diseases Research Center · Updated on 2024-08-12
23
Participants Needed
2
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Capsule Endoscopy for Severe Hematochezia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 witnessed by a health care provider
- Decrease in hemoglobin from baseline of 2 or more grams and/or transfusion of 1 or more units of red blood cells for resuscitation
- Severe hematochezia started either outpatient or inpatient
You will not qualify if you...
- Uncooperative or unable to give written informed consent personally or through a legal surrogate
- Contraindication to capsule endoscopy due to documented or suspected bowel obstruction, anatomical GI abnormalities such as strictures, inability to swallow the capsule, or presence of cardiac pacemakers or other implanted electromedical devices
- American Society of Anesthesiology (ASA) class V with very severe co-morbidities and poor prognosis for surgery
- Very severe GI bleeding with shock not responsive to IV fluid resuscitation, transfusions, and IV blood pressure medications
- History of recent hematemesis within 30 days or positive nasogastric/orogastric aspirate suggesting upper GI bleed
- Presenting with recurrent hematochezia previously diagnosed as anorectal bleeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
Actively Recruiting
2
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Not Yet Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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