UnknownNot Applicable

Standard Endoscopic Hemostasis Versus OVESCO Severe Non-variceal UGI Hemorrhage

United States65 participantsStarted 2015-11-15

Plain-language 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.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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. Exclusion Criteria: * 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The rebleeding rate of non-variceal focal UGI lesions

Timeframe: Outcome measure will be assessed at 30 days after participants are enrolled

Trial details

NCT IDNCT03065465

SponsorCURE Digestive Diseases Research Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-24

Contact for this trial

Dennis M Jensen, MD

310-268-3569 djensen@mednet.ucla.edu

View on ClinicalTrials.gov More Upper Gastrointestinal Hemorrhage trials