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Hemostasis Device

Hemoclipping vs Standard Treatment for Upper GI Bleeding

N/A

Recruiting

Led By Dennis M Jensen, MD

Research Sponsored by CURE Digestive Diseases Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of a benign appearing peptic ulcer, anastomotic ulcer, or Dieulafoy's lesion, with some SRH on endoscopy.

Clinical evidence of severe UGIB.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up outcome measure will be assessed at 30 days after participants are enrolled

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medical device that clips onto bleeding areas in the stomach to stop bleeding more effectively. It targets patients with severe stomach bleeding who often experience rebleeding after standard treatments. The device works by grabbing larger areas of tissue and blood vessels to reduce rebleeding. The new clip overcomes limitations of standard clips and achieves a more efficient and reliable stopping of bleeding in the upper gastrointestinal tract.

Who is the study for?

This trial is for people with severe non-variceal upper GI bleeding, specifically from ulcers or Dieulafoy's lesions. Participants must be able to give consent, have a life expectancy of at least 30 days without severe terminal illness, and show signs of active bleeding on endoscopy.

What is being tested?

The study compares two treatments for stopping severe upper GI bleeding: a new device called an over-the-scope-clip versus the standard treatment. Patients will be randomly assigned to one of these methods to see which is more effective at preventing rebleeding within 30 days.

What are the potential side effects?

Potential side effects may include discomfort or pain at the site of application, possible complications from endoscopic procedures like perforation or infection, and specific risks associated with each hemostasis method that will be detailed by the study team.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a non-cancerous stomach or intestinal ulcer seen during an endoscopy.

Select...

I have severe upper gastrointestinal bleeding.

Select...

I have severe bleeding in my upper digestive system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ outcome measure will be assessed at 30 days after the endoscopy treatment is completed

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~outcome measure will be assessed at 30 days after the endoscopy treatment is completed

This trial's timeline: 3 weeks for screening, Varies for treatment, and outcome measure will be assessed at 30 days after the endoscopy treatment is completed for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The rebleeding rate of non-variceal focal UGI lesions

Secondary study objectives

Obliteration rates of underlying arterial blood flow (detected by Doppler endoscopic probe)

Rates of surgery or IR, complications, and death

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard endoscopic treatmentExperimental Treatment1 Intervention

For those assigned to the standard endoscopy group, endoscopic hemostasis is performed using usual CURE hemostasis therapy for the focal GI lesions: injection of dilute (e.g. 1: 20,000) epinephrine (in 1-2 cc aliquots in 4 quadrants next to the SRH) of active bleeding or adherent clots (prior to snaring them off); coaptive coagulation with multipolar electrocautery (MPEC) probe and/or standard through the endoscope hemoclips along the course of the underlying artery as detected by DEP. Hemostasis is performed until active bleeding stops and/or the SRH is obliterated. Residual blood flow after visually guided hemostasis is recorded, but not used as a guide for additional hemostasis in this study.

Group II: Over-the-scope hemoclipping deviceExperimental Treatment1 Intervention

For those assigned OTSC, prior to use of the OTSC in UGI lesions with active bleeding or adherent clots, dilute epinephrine (1: 20,000) is injected around the SRH in 1-2 cc aliquots and the clots are cold guillotined off, as previously described (2, 4, 17). As a brief additional description, after initial diagnosis and preparation of the lesion and SRH (as described for standard hemostasis), the therapeutic sized endoscope is removed and this or a diagnostic panendoscope will be affixed with the OTSC of appropriate size for the endoscope and the target lesion. The endoscope is re-introduced and passed to the bleeding site. The SRH is centered in the field of view and within the cap of the OTSC device. Using high suctioning and firm pressure to center the SRH, the lesion and SRH is captured into the cap and the OTSC is deployed by rotating the handle and thereby compressing the bleeding lesion and surrounding tissue with mechanical hemostasis.

0 / 3Eligibility criteria met