Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

December 31, 2013

Study Completion Date

June 30, 2014

Conditions
Variceal Hemorrhage
Interventions
DEVICE

Hemospray

"Patients will be resuscitated as needed to achieve hemodynamic stability in preparation for endoscopy within 24 hours of hospital admission.~once the bleeding point will be identified at endoscopy, the delivery catheter will be inserted through the endoscope and positioned toward the lesion, leaving 1-2 cm between the bleeding site and the catheter tip.~Hemospray will be then delivered in short spray bursts (for 1-2 seconds) until hemostasis was confirmed.~Once bleeding was controlled , the bleeding site will be observed for 5 minutes under endoscopy.~Oral food and fluid will be with held from the patient for 24 hours. Intravenous octreotide and esomeprazole will given for up to 24 hours. Patients will be closely monitored for signs of recurrent bleeding for 24 hours post procedure.~Recurrent bleeding will be diagnosed any patient experiencing recurrent bleeding will treated according to the institutional standard of care"

Trial Locations (2)

1070

Erasme Hospital , ULB, Brussels

12311

Theodor Bilharz Research Institute, Giza

All Listed Sponsors
collaborator

Université Libre de Bruxelles

OTHER

lead

Theodor Bilharz Research Institute

OTHER

NCT01783899 - Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding | Biotech Hunter | Biotech Hunter