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Standard Endoscopic Hemostasis Versus OVESCO Severe Non-variceal UGI Hemorrhage

NCT03065465 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-08-27

No results posted yet for this study

Summary

The primary specific aim is to perform a randomized controlled trial (RCT) to compare 30 day rebleed rates and other clinical outcomes of patients with severe, non-variceal upper GI hemorrhage (NVUGIH) - ulcers and Dieulafoy's lesions who are randomized as initial treatment with the new large over-the-scope-clip device for endoscopic hemostasis versus standard endoscopic hemostasis.

Conditions

  • Upper Gastrointestinal Hemorrhage

Interventions

DEVICE

Over-the-scope hemoclipping device

A endoscopic entrapment of tissue for control of bleeding or other applications.

OTHER

Standard endoscopic treatment

Standard therapy includes injection of dilute epinephrine, thermal coagulation with multipolar electrocautery (MPEC) probe, and/or hemoclips.

Sponsors & Collaborators

Principal Investigators

  • Dennis M Jensen, MD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-15
Primary Completion
2024-12-24
Completion
2025-02-28

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03065465 on ClinicalTrials.gov