CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
PerClot +2 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.

Search/NCT02835391
NCT02835391N/ACompleted
CompareCT.gov

A Prospective, Multi-Centre, Randomized, Safety and Effectiveness Study of PerClot Compared to Usual Care When Used During Gynaecology Procedures

CryoLife Europa·interventional·Posted Jul 18, 2016·Updated Sep 1, 2017

In Brief

A clinical study evaluating PerClot, Floseal, Surgicel, Surgiflo, Arista, and 1 other intervention for Endometriosis and 4 related conditions. Completed, enrolled 90 participants across 1 site.

Detailed Summary

This study is a post market, multi-centre, randomised study evaluating PerClot compared to usual care. PerClot is a CE marked device and is currently used as a haemostat in gynaecological surgery throughout Europe. The purpose of this study is to collect additional post market data on its use in this indication.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometriosis, Ovarian Cyst, Menorrhagia, Cancer, Uterine Fibroids
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 18, 2016
Enrollment StartNov 1, 2015
Primary CompletionJul 1, 2017
Study CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.0 years ago

Interventions

PerClotdevice

Haemostatic device for the control of bleeding from capillary, venous or arteriolar vessels by pressure, ligature or other conventional means is either ineffective or impractical.

Floseal, Surgicel, Surgiflo, Aristadevice

Haemostatic device for the control of bleeding

Electrocautery/Diatermyprocedure

Procedure for the control of bleeding