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NCT02221128 Clinical Trial

PerClot to Control Bleeding in Endoscopic Sinus Surgery

Sinusitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02221128
Other study ID # PCT1402.001M(06/14)
Secondary ID
Status Completed
Phase N/A
First received July 3, 2014
Last updated October 2, 2014
Start date July 2014
Est. completion date September 2014

Study information
Verified date July 2014
Source CryoLife Europa
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Guys and St Thomas NHS Trust London

Sponsors (2)
Lead Sponsor Collaborator
CryoLife Europa CryoLife, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of subjects who achieve of haemostasis after the application of PerClot intraoperatively No
Secondary Number of subjects who require the use of alternative methods to achieve haemostasis after the application of PerClot intraoperatively No
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