Trial of Hemospray Plus Epinephrine Injection Versus Endoscopic Hemoclip

• Status: Unknown status
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo General Hospital
• Treatments: Epinephrine; Epinephryl borate; Racepinephrine

Criteria

Inclusion Criteria:

• Patients with a clinical diagnosis of upper gastrointestinal bleeding and that during endoscopy revealed to non-varicose bleeding lesions in the endoscopic treatment being necessary.

Exclusion Criteria:

• Pregnancy and History of endoscopic haemostatic procedure in the previous seven days