Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding

NCT01783899 | Completed

• 1 other identifier: Hemospray Varices
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

Brief Summary

The objective of this study is to assess the effectiveness of Hemospray in achieving initial hemostasis and decreased rate of re-bleeding in patients of acute variceal bleeding.

Conditions

Variceal Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Safety

  Safety will be characterized by the incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or device that are experienced by study participants.

  24 hours

Secondary Outcomes (1)

• Effectiveness

  24 hours

Study Arms (1)

Hemospray Group

EXPERIMENTAL

Hemospray device consists of a syringe containing the Hemospray powder (21 g per syringe), a delivery catheter that will be inserted into the working channel of the endoscope, and an introducer handle with a built-in carbon dioxide canister to propel the Hemospray powder out of the catheter. In addition to Hemospray device any other required endoscopic accessories can be used during the procedure.

Device: Hemospray

Interventions

Hemospray DEVICE

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

Hemospray Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Years and older
• Bleeding Esophageal and / or Gastric varices

You may not qualify if:

• Patient is: \< 18 years of age
• Unable to consent
• Contraindicated to undergo endoscopy,
• Already hospitalized for another illness
• Pregnant or lactating
• Patients with altered post-surgical anatomy of the stomach
• Previously placed intrahepatic portosystemic shunt
• Patient treated by other endoscopic or surgical modalities within 7 days prior to the intended application of Hemospray

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead
• Université Libre de Bruxelles: collaborator

Study Sites (2)

Erasme Hospital , ULB

Brussels, 1070, Belgium

Location

Theodor Bilharz Research Institute

Giza, 12311, Egypt

Location

Related Publications (1)

• Ibrahim M, El-Mikkawy A, Mostafa I, Deviere J. Endoscopic treatment of acute variceal hemorrhage by using hemostatic powder TC-325: a prospective pilot study. Gastrointest Endosc. 2013 Nov;78(5):769-73. doi: 10.1016/j.gie.2013.07.037.

  PMID: 24120338 DERIVED

Study Officials

• Mostafa Ibrahim, MD

  Université Libre de Bruxelles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist

Study Record Dates

• First Submitted: February 1, 2013
• First Posted: February 5, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: December 30, 2014

Record last verified: 2014-12

Locations

EG (1); BE (1)