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Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding

NCT01783899 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-12-30

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Université Libre de Bruxelles

    collaborator OTHER

  • Theodor Bilharz Research Institute

    lead OTHER

Principal Investigators

  • Mostafa Ibrahim, MD · Université Libre de Bruxelles

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-12-31
Completion
2014-06-30

Countries

  • Belgium
  • Egypt

Study Locations

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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 NCT01783899 on ClinicalTrials.gov