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PerClot to Control Bleeding in Endoscopic Sinus Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02221128
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : October 3, 2014
Information provided by (Responsible Party):

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

Condition or disease

Study Design

Study Type : Observational
Actual Enrollment : 12 participants
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
Study Start Date : July 2014
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Sinusitis
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT02221128     History of Changes
Other Study ID Numbers: PCT1402.001M(06/14)
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: October 3, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases