CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 27 enrolled
Drug / intervention
HEMOBLAST Bellowsdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02502019
NCT02502019Phase 1Completed
CompareCT.gov

Prospective, Multicenter, Single-arm Pilot Clinical Investigation Evaluating the Use of a Surface Bleeding Severity Scale (SBSS) and the Safety and Efficacy of a New Hemostatic Device in Abdominal and Orthopedic Lower Extremity Surgeries

Biom'Up France SAS·interventional·Posted Jul 17, 2015·Updated Feb 15, 2019

In Brief

A Phase 1 clinical trial evaluating HEMOBLAST Bellows for Hemostasis. Completed, enrolled 27 participants across 3 sites.

Detailed Summary

The primary objective of this pilot clinical investigation is to assess the reliability of the Surface Bleeding Severity Scale (SBSS) in a clinical setting. Secondary objectives of this clinical investigation are to collect initial data on the safety and efficacy of HEMOBLAST™ Bellows in abdominal and orthopedic lower extremity surgeries.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemostasis
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 17, 2015
Enrollment StartAug 1, 2015
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.0 years ago

Interventions

HEMOBLAST Bellowsdevice

HEMOBLAST™ Bellows is intended for use in surgical procedures as an adjunct to hemostasis when control of bleeding by conventional procedures is ineffective or impractical.