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Trial of Hemospray Plus Epinephrine Injection Versus Endoscopic Hemoclip

NCT02537353 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-09-01

No results posted yet for this study

Summary

The non-variceal upper gastrointestinal bleeding is defined as gastrointestinal bleeding located proximal to the angle of Treitz, whose cause is not related to esophagogastric varices or gastropathy of portal hypertension.

Animal studies showed no absorption in the GIT and disposal within 48 hours of application, and no reported cases of obstruction. Recently, a prospective study involving 20 patients with upper gastrointestinal bleeding, showed that the application of hemospray ® promoted hemostasis in 95% of cases, confirmed by endoscopic revision 72h after application without any complication.

Conditions

  • Upper Gastrointestinal Bleeding

Interventions

DEVICE

Metal clips

The group will be shot of adrenaline 1: 10,000 in four quadrants, associated with application of metal clips.

DRUG

Hemospray

The group will be shot of adrenaline 1: 10,000 in the four quadrants associated with application adsorption powder, marketed under the name Hemospray.

PROCEDURE

Endoscopy Exam

All patients will be submitted to endoscopy exam in 12 to 24 hours after the therapeutic procedure to confirm the success of the therapy and measure if there the presence of rebleeding.

DRUG

Adrenaline

The injection of adrenaline solution with 50% glucose at a proportion of 1: 10000 in four quadrants.

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Felipe I Baracat · Hospital das Clínicas FMUSP

  • Eduardo GH de Moura · Hospital das Clínicas FMUSP

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-07-31
Completion
2017-08-31

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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 NCT02537353 on ClinicalTrials.gov