PerClot to Control Bleeding in Endoscopic Sinus Surgery

NCT ID: NCT02221128

Last Updated: 2014-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-09-30

Brief Summary

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

Detailed Description

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Conditions

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Sinusitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CryoLife, Inc.

INDUSTRY

Sponsor Role collaborator

CryoLife Europa

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Roberts

Role: PRINCIPAL_INVESTIGATOR

Guy's and St Thomas' NHS Foundation Trust

Locations

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Guys and St Thomas NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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PCT1402.001M(06/14)

Identifier Type: -

Identifier Source: org_study_id

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