PerClot to Control Bleeding in Endoscopic Sinus Surgery

A Post Market Surveillance Study Evaluating the Safety and Effectiveness of PerClot to Control Mild Bleeding in Subjects Undergoing Endoscopic Sinus Surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02221128

Enrollment

Registered

2014-08-20

Start date

2014-07-31

Completion date

2014-09-30

Last updated

2014-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinusitis

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of subjects who achieve of haemostasis after the application of PerClot	intraoperatively

Secondary

Measure	Time frame
Number of subjects who require the use of alternative methods to achieve haemostasis after the application of PerClot	intraoperatively

Countries

United Kingdom

Outcome results