PerClot to Control Bleeding in Endoscopic Sinus Surgery | NCT02221128

Studies
PerClot to Control Bleeding in Endoscopic Sinus Surgery

NCT02221128

Sponsor

CryoLife Europa

Status

Completed

Last Update Posted

Oct 3, 2014Estimated

Enrollment

12Actual

Phase

Not provided

Conditions

Sinusitis

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Jul 3, 2014

First Submission Date that Met QC Criteria

Aug 19, 2014

First Posted Date

Aug 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2014

Last Update Posted Date

Oct 3, 2014Estimated

Name	Class
CryoLife, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults undergoing Endoscopic Sinus Surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Roberts	Guy's and St Thomas' NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guys and St Thomas NHS Trust		London		SE1 9RT	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D012852	Sinusitis

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010254	Paranasal Sinus Diseases
D009668	Nose Diseases

Browse Leaves

Not provided

Browse Branches

Not provided