We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

PerClot to Control Bleeding in Endoscopic Sinus Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02221128
First Posted: August 20, 2014
Last Update Posted: October 3, 2014
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.
Collaborator:
CryoLife, Inc.
Information provided by (Responsible Party):
CryoLife Europa
  Purpose
A prospective, single centre, single arm study designed to collect clinical data on PerClot when used in subjects undergoing endoscopic sinus surgery.

Condition
Sinusitis

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)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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
  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


Locations
United Kingdom
Guys and St Thomas NHS Trust
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
CryoLife Europa
CryoLife, Inc.
Investigators
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 Submitted: July 3, 2014
First Posted: August 20, 2014
Last Update Posted: October 3, 2014
Last Verified: July 2014

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