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OpenTrials
Completed

NCT Number: NCT02221128

PerClot to Control Bleeding in 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guys and St Thomas NHS Trust

London, SE1 9RT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of subjects who achieve of haemostasis after the application of PerClot

    Time frame: intraoperatively

Secondary outcomes

  1. Number of subjects who require the use of alternative methods to achieve haemostasis after the application of PerClot

    Time frame: intraoperatively

Sponsors and collaborators

Lead sponsor

CryoLife Europa

Industry

Collaborators

  • CryoLife, Inc.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 20, 2014
Registry last updated
Oct 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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