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PerClot to Control Bleeding in Endoscopic Sinus Surgery

This study has been completed.
Sponsor:
Collaborator:
CryoLife, Inc.
Information provided by (Responsible Party):
CryoLife Europa
ClinicalTrials.gov Identifier:
NCT02221128
First received: July 3, 2014
Last updated: October 2, 2014
Last verified: July 2014
  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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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)
Study First Received: July 3, 2014
Last Updated: October 2, 2014

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

ClinicalTrials.gov processed this record on June 22, 2017