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Hemostasis Device

Over-the-scope hemoclipping device for Upper Gastrointestinal Bleeding

N/A

Waitlist Available

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial will compare the rebleed rates and other clinical outcomes of patients with severe, non-variceal upper GI hemorrhage who are treated with a new large over-the-scope-clip device for endoscopic hemostasis versus standard endoscopic hemostasis.

Eligible Conditions

Upper Gastrointestinal Bleeding

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and outcome measure will be assessed at 30 days after participants are enrolled for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The rebleeding rate of non-variceal focal UGI lesions

Secondary outcome measures

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

Rates of surgery or IR, complications, and death

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Greater Los Angeles Healthcare SystemFED

51 Previous Clinical Trials

8,504 Total Patients Enrolled

CURE Digestive Diseases Research CenterLead Sponsor

1 Previous Clinical Trials

50 Total Patients Enrolled

University of California, Los AngelesOTHER

1,528 Previous Clinical Trials

10,276,786 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment offering an opportunity to those aged seventy-five or older?

"According to the rules of engagement for this clinical test, participants aged 18-100 are welcome to apply."

Answered by AI

May I be considered as a participant in this trial?

"In order to take part in this clinical trial, patients must have experienced haemorrhage and be between 18 to 100 years old. The team is aiming to recruit a total of 65 individuals."

Answered by AI

What is the aggregate number of people participating in this experiment?

"Correct. Per clinicaltrials.gov, this medical trial is actively enrolling participants; it was initially posted on November 15th 2015 and updated most recently on March 21st 2022. 65 patients are needed across two sites for the successful completion of the study."

Answered by AI

Are there any current recruitment initiatives for this research?

"Affirmative, clinicaltrials.gov indicates that this trial is actively seeking participants. It was first shared on November 15th 2015 and most recently updated on March 21st 2022. 65 patients will be enrolled from two different medical sites."

Answered by AI

Recent research and studies

Surgical EndoscopyJournal

Over-the-scope Clip (OTSC) Represents an Effective Endoscopic Treatment for Acute GI Bleeding After Failure of Conventional Techniques

Manta, Raffaele, Giuseppe Galloro, Benedetto Mangiavillano, Rita Conigliaro, Luigi Pasquale, Alberto Arezzo, Enzo Masci, Gabrio Bassotti, and Marzio Frazzoni. 2013. “Over-the-scope Clip (OTSC) Represents an Effective Endoscopic Treatment for Acute GI Bleeding After Failure of Conventional Techniques”. Surgical Endoscopy. Springer Science and Business Media LLC. doi:10.1007/s00464-013-2871-1.

Surgical EndoscopyJournal

Multicenter Evaluation of First-line Endoscopic Treatment with the OTSC in Acute Non-variceal Upper Gastrointestinal Bleeding and Comparison with the Rockall Cohort: The Fletrock Study

Wedi, E., A. Fischer, J. Hochberger, C. Jung, S. Orkut, and H. J. Richter-Schrag. 2017. “Multicenter Evaluation of First-line Endoscopic Treatment with the OTSC in Acute Non-variceal Upper Gastrointestinal Bleeding and Comparison with the Rockall Cohort: The Fletrock Study”. Surgical Endoscopy. Springer Science and Business Media LLC. doi:10.1007/s00464-017-5678-7.

American Journal of GastroenterologyJournal

Management of Patients with Ulcer Bleeding

Laine, Loren, and Dennis M Jensen. 2012. “Management of Patients with Ulcer Bleeding”. American Journal of Gastroenterology. Ovid Technologies (Wolters Kluwer Health). doi:10.1038/ajg.2011.480.

Endoscopy International OpenJournal