Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID03616041

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

Led by CURE Digestive Diseases Research Center · Updated on 2024-08-12

23

Participants Needed

2

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of a second-generation colon capsule endoscopy system to detect bleeding sources in patients with severe hematochezia, which involves bright red blood per rectum. This study compares this capsule endoscopy with standard diagnostic tests like tagged red blood cell scans and angiography to see if it improves the accuracy and speed of locating bleeding lesions. The study aims to provide a new approach that could change current guidelines and management for patients with this condition. Participants will undergo bowel preparation and then swallow the colon capsule, which records images of the entire gastrointestinal tract for up to 10 hours. Alongside this, patients will receive standard tests such as tagged RBC scans, CT or MRI angiography, and urgent colonoscopy within 48 hours to identify bleeding sources. The study also includes further diagnostic procedures if needed, and specialists will review all results while blinded to the capsule endoscopy findings initially to avoid bias. During the study, researchers will collect medical history, physical exams, lab tests, and details about bleeding and treatments. Safety monitoring will track adverse events daily during hospitalization and weekly for 30 days after discharge. The main outcome measured is the ability of each diagnostic method to locate the bleeding site within 30 days. Follow-up includes monitoring treatments, complications, transfusions, hospital stay, and survival, with data kept confidential and securely managed throughout the study.

CONDITIONS

Brief Title

Capsule Endoscopy for Severe Hematochezia

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or older
  • Able to provide written informed consent or have a legal surrogate who can provide consent
  • Presenting with severe ongoing hematochezia witnessed by a healthcare provider
  • Hemoglobin drop of 2 or more grams from baseline and/or transfusion of 1 or more units of red blood cells for resuscitation
  • Severe hematochezia starting as outpatient or inpatient
Not Eligible

You will not qualify if you...

  • Uncooperative or unable to provide informed consent personally or via surrogate, or refuse to participate
  • Contraindications to capsule endoscopy including documented or suspected bowel obstruction, anatomical GI abnormalities such as strictures, inability to swallow the capsule, or presence of cardiac pacemakers or implanted electromedical devices
  • American Society of Anesthesiology (ASA) class V with very severe co-morbidities and poor surgical prognosis
  • Very severe GI bleeding with shock not responsive to IV fluids, transfusions, or medications
  • Recent hematemesis within 30 days or positive nasogastric/orogastric aspirate suggesting upper GI bleed
  • Recurrent hematochezia previously diagnosed as anorectal bleeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 48 hours

Participants undergo diagnostic tests including swallowing a second-generation colon capsule to record images of their gastrointestinal tract, along with standard diagnostic tests like tagged RBC scan, computerized tomographic angiography (CTA), conventional angiography, and urgent colonoscopy to help localize the source of bleeding.

1 to 2 visits depending on diagnostic procedures

Long-term Monitoring

Duration - Up to 30 days after discharge

Participants are monitored for safety and clinical outcomes including bleeding recurrence, complications, and recovery during hospitalization and for 30 days after discharge.

Daily assessments while hospitalized and weekly follow-up visits after discharge

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

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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

Frequently Asked Questions

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Published Research Related To This Trial

Time trends and impact of upper and lower gastrointestinal bleeding and perforation in clinical practice.

Angel Lanas, Luis A García-Rodríguez, Mónica Polo-Tomás...

https://pubmed.ncbi.nlm.nih.gov/19574968

Natural history of definitive diverticular hemorrhage based on stigmata of recent hemorrhage and colonoscopic Doppler blood flow monitoring for risk stratification and definitive hemostasis.

Dennis M Jensen, Gordon V Ohning, Thomas O G Kovacs...

https://pubmed.ncbi.nlm.nih.gov/26227931

Major stigmata of recent hemorrhage on rectal ulcers in patients with severe hematochezia: Endoscopic diagnosis, treatment, and outcomes.

Fasiha Kanwal, Gareth Dulai, Dennis M Jensen...

https://pubmed.ncbi.nlm.nih.gov/12665754