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PerClot to Control Bleeding in Endoscopic Sinus Surgery

This study has been completed.
CryoLife, Inc.
Information provided by (Responsible Party):
CryoLife Europa Identifier:
First received: July 3, 2014
Last updated: October 2, 2014
Last verified: July 2014
A prospective, single centre, single arm study designed to collect clinical data on PerClot when used in subjects undergoing endoscopic sinus surgery.


Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Post Market Surveillance Study Evaluating the Safety and Effectiveness of PerClot to Control Mild Bleeding in Subjects Undergoing Endoscopic Sinus Surgery

Resource links provided by NLM:

Further study details as provided by CryoLife Europa:

Primary Outcome Measures:
  • Number of subjects who achieve of haemostasis after the application of PerClot [ Time Frame: intraoperatively ]

Secondary Outcome Measures:
  • Number of subjects who require the use of alternative methods to achieve haemostasis after the application of PerClot [ Time Frame: intraoperatively ]

Enrollment: 12
Study Start Date: July 2014
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults undergoing Endoscopic Sinus Surgery

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT02221128

United Kingdom
Guys and St Thomas NHS Trust
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
CryoLife Europa
CryoLife, Inc.
Principal Investigator: David Roberts Guy's and St Thomas' NHS Foundation Trust
  More Information

Responsible Party: CryoLife Europa Identifier: NCT02221128     History of Changes
Other Study ID Numbers: PCT1402.001M(06/14)
Study First Received: July 3, 2014
Last Updated: October 2, 2014

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases processed this record on September 19, 2017