At a glance
ClinicalIndex Comparison RecordN/ACompleted· 258 enrolled
Drug / intervention
HEMOBLAST Bellows +1 moredevice
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.
Prospective, Randomized, Controlled, Multicenter, Pivotal, Clinical Investigation Evaluating the Safety and Efficacy of HEMOBLAST Bellows in Cardiothoracic, Abdominal, and Orthopedic Lower Extremity Surgeries
In Brief
A clinical study evaluating HEMOBLAST Bellows and Absorbable gelatin sponge, USP with thrombin for Hemostasis. Completed, enrolled 258 participants across 17 sites.
Detailed Summary
The purpose of this prospective, randomized, controlled study is to evaluate the safety and efficacy of a new hemostatic device (HEMOBLAST™ Bellows) compared to a control device, absorbable gelatin sponge USP with thrombin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemostasis
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartJul 2016
Primary CompletionFeb 2017
Study CompletionMar 2017
TodayJul 2026
First PostedMay 24, 2016
Enrollment StartJul 18, 2016
Primary CompletionFeb 1, 2017
Study CompletionMar 27, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 10.1 years ago
Interventions
HEMOBLAST Bellowsdevice
Absorbable gelatin sponge, USP with thrombindevice