At a glance
ClinicalIndex Comparison RecordN/ACompleted· 65 enrolled
Drug / intervention
PuraStat®device
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.
A Multi-center, Single Arm Post-market Clinical Study to Confirm Safety and Performance of PuraStat® Absorbable Haemostatic Material for the Management of Bleeding In Vascular Surgery.
In Brief
An observational study evaluating PuraStat® for Vascular Anastomosis Surgery. Completed, enrolled 65 participants across 1 site.
Detailed Summary
The objective of this post-market clinical follow-up study is to collect medical information on patients implanted with PuraStat®, according to each participating institution's procedures and standards of care.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsVascular Anastomosis Surgery
CountriesUnited Kingdom
Collaborators--
Timeline
N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartJun 2017
Primary CompletionJul 2019
Study CompletionAug 2019
TodayJul 2026
First PostedApr 6, 2017
Enrollment StartJun 14, 2017
Primary CompletionJul 5, 2019
Study CompletionAug 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.2 years ago
Interventions
PuraStat®device
Synthetic haemostatic material