Recruiting

Capsule Endoscopy

Sponsor:

CURE Digestive Diseases Research Center

Code:

NCT03616041

Conditions

Hematochezia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Second-generation colon capsule endoscopy system

Study Details

Brief 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

Study ID

NCT03616041

Start date

Feb 10, 2021

Status verified date

Aug, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Oct 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 18 years old or older
2. Able to provide written informed consent or have a legal surrogate who can provide written consent
3. 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.

Exclusion Criteria:

1. Uncooperative, unable to give written informed consent personally or through a legal surrogate, or refuse to participate
2. Contraindication to undergo capsule endoscopy due to:

1. Documented or suspected bowel obstruction (partial or complete)
2. Anatomical GI abnormalities such as strictures of the foregut or small bowel
3. Inability to swallow the capsule
4. Presence of cardiac pacemakers or other implanted electromedical devices
3. American Society of Anesthesiology (ASA) class V (very severe co-morbidities and very poor prognosis for surgery or similar procedures)
4. Very severe GI bleeding with shock not responsive to IV fluid resuscitation and/or transfusions and IV medications to raise the systolic blood pressure
5. History of recent hematemesis (within 30 days), positive nasogastric, or orogastric (OG) aspirate suggesting an upper GI bleed
6. Presenting with recurrent hematochezia that has been previously diagnosed as anorectal bleeding

Study Design

Enrollment

23 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • The diagnostic yield tests in detecting a bleeding site and comparison of rates [ Time Frame: 30 days ]

Central Contacts and Locations

Locations

VA Greater Los Angeles Healthcare System

Recruiting

Los Angeles, California, United States, 90073

Contacts

Principal Investigator:

Dennis M Jensen, MD

More Information

Sponsor

CURE Digestive Diseases Research Center

Last update posted

Aug 12, 2024

Last verified

Aug, 2024

Keywords

  • Severe hematochezia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CURE Digestive Diseases Research Center on 2024-08-12.