Standard Endoscopic Hemostasis Versus OVESCO Severe Non-variceal UGI Hemorrhage

Description

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

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Study Overview

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Study Details

Study overview

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.

Randomized Controlled Trial (RCT) of Standard Endoscopic Hemostasis Compared to OVESCO for Severe Non-variceal UGI Hemorrhage

Standard Endoscopic Hemostasis Versus OVESCO Severe Non-variceal UGI Hemorrhage

Condition
Upper Gastrointestinal Hemorrhage
Intervention / Treatment

-

Contacts and Locations

Los Angeles

VA Greater Los Angeles Healthcare System, Los Angeles, California, United States, 90073

Los Angeles

University of California, Los Angeles, Los Angeles, California, United States, 90095

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Written informed consent from the patient or a surrogate.
  • * Clinical evidence of severe UGIB.
  • * Presence of a benign appearing peptic ulcer, anastomotic ulcer, or Dieulafoy's lesion, with some SRH on endoscopy.
  • * Severe upper GI bleeding.
  • * Life expectancy of at least 30 days based on lack of severe or terminal comorbidity as judged by the generalist or subspecialist caring for the patient.
  • * Patients who are do-not-resuscitate (DNR) that is not reversible, uncooperative, refuse to participate, or are unable to give consent personally or through a legal surrogate.
  • * Active GI malignancy, under treatment but not in remission.
  • * Acute hypovolemic shock that is unresponsive to transfusion of 5 or more units of red blood cells (RBC's) or requires continuous intravenous vasopressor infusion for blood pressure support.
  • * ASA (American Society of Anesthesiology) class V or higher, moribund, or with a very poor prognosis and expected survival \<30 days.
  • * Severe coagulopathy or thrombocytopenia despite attempted reversal with transfusion of blood products (e.g persistent International Normalized Ratio \[INR\] \>2.0, platelet count \<20,000, a Partial Thromboplastin Time \[PTT\] greater than 2x upper limit of normal).
  • * Absolute contraindication to urgent endoscopy (such as suspected perforated viscus, or peritonitis).
  • * Stricture of the esophagus or pylorus that can not be dilated or precludes passage of a diagnostic sized endoscope and/or the GI endoscope with an 11, 3a OTSC device attached.

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

CURE Digestive Diseases Research Center,

Dennis M Jensen, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

2025-02-28