PerClot to Control Bleeding in Endoscopic Sinus Surgery
October 2, 2014 updated by: CryoLife Europa
A Post Market Surveillance Study Evaluating the Safety and Effectiveness of PerClot to Control Mild Bleeding in Subjects Undergoing Endoscopic Sinus Surgery
A prospective, single centre, single arm study designed to collect clinical data on PerClot when used in subjects undergoing endoscopic sinus surgery.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, SE1 9RT
- Guys and St Thomas NHS Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adults undergoing Endoscopic Sinus Surgery
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of subjects who achieve of haemostasis after the application of PerClot
Time Frame: intraoperatively
|
intraoperatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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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intraoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David Roberts, Guy's and St Thomas' NHS Foundation Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
July 3, 2014
First Submitted That Met QC Criteria
August 19, 2014
First Posted (Estimate)
August 20, 2014
Study Record Updates
Last Update Posted (Estimate)
October 3, 2014
Last Update Submitted That Met QC Criteria
October 2, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCT1402.001M(06/14)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.