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PerClot to Control Bleeding in Endoscopic Sinus Surgery

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ClinicalTrials.gov Identifier: NCT02221128
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : October 3, 2014
Sponsor:
Collaborator:
CryoLife, Inc.
Information provided by (Responsible Party):
CryoLife Europa

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
Sinusitis

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
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

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




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 ]


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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
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

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

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:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases