NCT02221128

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 3, 2014

Status Verified

July 1, 2014

Enrollment Period

2 months

First QC Date

July 3, 2014

Last Update Submit

October 2, 2014

Conditions

Sinusitis

Outcome Measures

Primary Outcomes (1)

  • Number of subjects who achieve of haemostasis after the application of PerClot

    intraoperatively

Secondary Outcomes (1)

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

    intraoperatively

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults undergoing Endoscopic Sinus Surgery

You may qualify if:

  • 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

You may not qualify if:

  • Subjects unable or unwilling to give consent for their data to be collected

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guys and St Thomas NHS Trust

London, SE1 9RT, United Kingdom

Location

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • David Roberts

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2014

First Posted

August 20, 2014

Study Start

July 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

October 3, 2014

Record last verified: 2014-07

Locations

GB(1)