Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding

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.

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Key information

Conditions

Variceal Hemorrhage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasme Hospital , ULB, Brussels, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 Years and older
Bleeding Esophageal and / or Gastric varices

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

Safety

Time frame: 24 hours

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.

Secondary outcomes

Effectiveness

Time frame: 24 hours

Information on efficacy will be obtained by measurements the proportion of patients with acute (procedural) hemostasis, and the rate of recurrent bleeding within 72 hours of treatment.

Sponsors and collaborators

Lead sponsor

Theodor Bilharz Research Institute

Other

Collaborators

Université Libre de Bruxelles

Registry information

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2014
First posted: Feb 5, 2013
Registry last updated: Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed