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Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding

Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01783899
Enrollment
30
Registered
2013-02-05
Start date
2013-01-31
Completion date
2014-06-30
Last updated
2014-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Variceal Hemorrhage

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.

Interventions

DEVICEHemospray

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

Université Libre de Bruxelles
CollaboratorOTHER
Theodor Bilharz Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Safety24 hoursSafety 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

MeasureTime frameDescription
Effectiveness24 hoursInformation 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.

Countries

Belgium, Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026