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PerClot Compared to Usual Care in Gynaecology Procedures

NCT02835391 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2017-09-01

No results posted yet for this study

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.

Conditions

  • Endometriosis
  • Ovarian Cyst
  • Menorrhagia
  • Cancer
  • Uterine Fibroids

Interventions

DEVICE

PerClot

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.

DEVICE

Floseal, Surgicel, Surgiflo, Arista

Haemostatic device for the control of bleeding

PROCEDURE

Electrocautery/Diatermy

Procedure for the control of bleeding

Sponsors & Collaborators

  • CryoLife Europa

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-07-31
Completion
2017-08-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02835391 on ClinicalTrials.gov