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Clinical Trials/NCT02221128
NCT02221128
Completed
Not Applicable

A Post Market Surveillance Study Evaluating the Safety and Effectiveness of PerClot to Control Mild Bleeding in Subjects Undergoing Endoscopic Sinus Surgery

CryoLife Europa1 site in 1 country12 target enrollmentJuly 2014
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ConditionsSinusitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sinusitis
Sponsor
CryoLife Europa
Enrollment
12
Locations
1
Primary Endpoint
Number of subjects who achieve of haemostasis after the application of PerClot
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

A prospective, single centre, single arm study designed to collect clinical data on PerClot when used in subjects undergoing endoscopic sinus surgery.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
September 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
CryoLife Europa
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Subjects having Endoscopic Sinus Surgery
  • •Subjects who will have PerClot used as a haemostatic agent
  • •Subjects willing and able to give consent
  • •Subjects over 18 years old

Exclusion Criteria

  • •Subjects unable or unwilling to give consent for their data to be collected

Outcomes

Primary Outcomes

Number of subjects who achieve of haemostasis after the application of PerClot

Time Frame: intraoperatively

Secondary Outcomes

  • Number of subjects who require the use of alternative methods to achieve haemostasis after the application of PerClot(intraoperatively)

Study Sites (1)

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