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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02595853
Other study ID # RC14_0077
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2014
Est. completion date January 2015

Study information

Verified date September 2021
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hemospray™ is a new endoscopic hemostatic powder. Aims of this multicenter prospective study is to determine effectiveness of Hemospray™ on short and medium term in different clinical situations, predictive factors of rebleeding after Hemospray™ application, and feasibility of the application of hemostatic powder in routine clinical practice studying in a large sample of patients.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female aged 18 and over who need the use of Hemospray® under their care in an emergency. - Upper gastrointestinal hemorrhage. - Patients who received the information note of the study and agreeing to participate (non-oral opposition gathered in the patient's medical record) Non Inclusion Criteria: - Patient under guardianship, curatorship. - Pregnant woman.

Study Design


Intervention

Other:
Non interventional study
All upper gastro-intestinal bleeding need endoscopic hemostasis. Endoscopic hemostasis conventional methods are injection of saline with epinephrine, placement of hemoclips and thermic or plasma coagulation. Hemospray™ will be sprayed onto bleeding lesions seen in endoscopy after failure of conventional methods or in salvage therapy at the discretion of endoscopists. Retrospective analysis of prospectively cellected data.

Locations

Country Name City State
France Angers University Hospital Angers
France Besançon University Hospital Besançon
France Bordeuax University Hospital Bordeaux
France Lille University Hospital Lille
France Limoges University Hospital Limoges
France La Conception University Hospital Marseille
France La Timone University Hospital Marseille
France Nantes University Hospital Nantes
France Nîmes University Hospital Nîmes
France Cochin University Hospital Paris
France Georges Pompidou University Hospital (AP-HP) Paris
France Henri Mondor University Hospital (AP-HP) Paris
France Lariboisière University Hospital (AP-HP) Paris
France Rouen University Hospital Rouen
France Saint-Brieuc University Hospital Saint-Brieuc
France Clinique des Cèdres Toulouse
France Tours University Hospital Tours
France Vichy Hospital Vichy
Monaco Monaco University Hospital Monaco

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Countries where clinical trial is conducted

France,  Monaco, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of immediate cessation of bleeding observed in first-line per procedure or after failure of normal hemostasis techniques. Percentage of immediate cessation of bleeding observed in first-line per procedure or after failure of normal hemostasis techniques. 30 days
Secondary Rebleeding rate at days 8 and 30, defined as the percentage of patients with >2g/dL hemoglobin AND/OR exteriorization of hematemesis AND/OR exteriorization of melena Rebleeding rate at days 8 and 30, defined as the percentage of patients with >2g/dL hemoglobin AND/OR exteriorization of hematemesis AND/OR exteriorization of melena 30 days
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