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Study of Early Endocapsule (EC) in Clinical Decision Unit Versus Standard of Care Work-up for GI Bleeding

NCT03955055 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-07-10

Study results available
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Summary

This study will evaluate the use of the Olympus EndoCapsule EC-10 video capsule compared with the standard of care workup for patients in the Clinical Decision Unit who have symptoms of gastrointestinal (GI) bleeding. Patients will be eligible if they have any symptoms of GI bleeding, either vomiting blood or symptoms without vomiting blood.

Patients randomized to the early capsule arm will have an immediate video capsule endoscopy. Patients randomized to the standard of care arm will have no study intervention and will follow the treating physician's diagnostic workup.

The primary goal of the study is to compare how often a source of bleeding is identified in patients in the two groups.

Conditions

  • Gastro Intestinal Bleeding
  • Hematemesis
  • Melena

Interventions

DEVICE

Video Capsule Endoscopy

Patients will swallow a video capsule as soon as possible (immediately or within 10 hours, if patient is not fasting).

Sponsors & Collaborators

  • Olympus Corporation of the Americas

    collaborator INDUSTRY

  • Christopher Marshall

    lead OTHER

Principal Investigators

  • Christopher Marshall, MD · UMass Medical School Assistant Professor of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-04
Primary Completion
2022-04-09
Completion
2022-04-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03955055 on ClinicalTrials.gov