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NCT03616041 · ClinicalTrials.gov registry record

Capsule Endoscopy for Severe Hematochezia

A clinical trial of Hematochezia, sponsored by CURE Digestive Diseases Research Center.

Recruiting
Registry status
23
Enrollment target
2
Study locations

NCT03616041 is a study of Hematochezia that is actively recruiting participants, run by CURE Digestive Diseases Research Center. The registered enrollment target is 23 participants. The trial reports 2 study locations across 1 state.

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The verdict

NCT03616041, a study of Hematochezia, is actively recruiting participants, sponsored by CURE Digestive Diseases Research Center.

RECRUITING
Registry status
23 participants
Enrollment target
2
Study locations

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 Studied

Interventions

  • DEVICE Second-generation colon capsule endoscopy system

Study Locations (2)

California

  • VA Greater Los Angeles Healthcare System - Los Angeles
  • Ronald Reagan UCLA Medical Center - Los Angeles

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2021-02-10
Est. Completion 2024-12-31

What the Registry Record Tells You About NCT03616041

The ClinicalTrials.gov registry entry for NCT03616041 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CURE Digestive Diseases Research Center, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hematochezia appearing as the primary indexed condition, and to 1 intervention - of which Second-generation colon capsule endoscopy system is the first listed.

NCT03616041 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT03616041 about?

NCT03616041 is a clinical study titled "Capsule Endoscopy for Severe Hematochezia". 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...

What is the current status of trial NCT03616041?

This trial is currently recruiting. The enrollment target is 23 participants. The study started on 2021-02-10. Estimated completion is 2024-12-31.

What conditions does trial NCT03616041 study?

This clinical trial studies the following conditions: Hematochezia.

What interventions are being tested in trial NCT03616041?

The interventions under investigation include: Second-generation colon capsule endoscopy system (DEVICE).

Who is sponsoring clinical trial NCT03616041?

This trial is sponsored by CURE Digestive Diseases Research Center, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03616041 being conducted?

This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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