SinusitisNCT02221128
PerClot to Control Bleeding in Endoscopic Sinus Surgery
An observational study of Sinusitis, run by CryoLife Europa at 1 site in United Kingdom.
Trial summary
A prospective, single centre, single arm study designed to collect clinical data on PerClot when used in subjects undergoing endoscopic sinus surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinusitis
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing Endoscopic Sinus Surgery
Who may be able to join
- 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
Who cannot join
- Subjects unable or unwilling to give consent for their data to be collected
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post Market Surveillance Study Evaluating the Safety and Effectiveness of PerClot to Control Mild Bleeding in Subjects Undergoing 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.
- Conditions
- Sinusitis
- Medical subject headings
- Sinusitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects who achieve of haemostasis after the application of PerClot
Measured: intraoperatively
Secondary outcomes (1)
Number of subjects who require the use of alternative methods to achieve haemostasis after the application of PerClot
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- CryoLife Europa
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CryoLife, Inc.
- Responsible party
- Sponsor
- Investigators
- David Roberts, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221128
- Sponsor's protocol ID
- PCT1402.001M(06/14)
- Status last verified
- Jul 2014
- First submitted
- 3 Jul 2014
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Surveillance Study Evaluating the Safety and Effectiveness of PerClot to Control Mild Bleeding in Subjects Undergoing Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT02221128
- Acronym / sponsor ID
- PCT1402.001M(06/14)
- Conditions
- Sinusitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- CryoLife EuropaIndustry (pharma, biotech, devices)
- Collaborators
- CryoLife, Inc.
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 20 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, single centre, single arm study designed to collect clinical data on PerClot when used in subjects undergoing endoscopic sinus surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing Endoscopic Sinus Surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects unable or unwilling to give consent for their data to be collected
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of subjects who achieve of haemostasis after the application of PerClot
Time frame: intraoperatively
1 secondary outcome
Number of subjects who require the use of alternative methods to achieve haemostasis after the application of PerClot
Time frame: intraoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Roberts principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sinusitis, run by CryoLife Europa at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects who achieve of haemostasis after the application of PerClot (time frame: intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2014.