Anorectal FistulaNCT03321266
Retrospective Review of the Cook Biodesign® Fistula Plug to Treat Anorectal Fistulas
An observational study of Anorectal Fistula, run by Cook Group Incorporated at 4 sites in 2 countries.
Trial summary
The study is a retrospective review of the use of the Biodesign® Fistula Plug (C-FPS-[X]). A total of 73 patients will be enrolled who have had a fistula plug placed to treat anorectal fistulas and will therefore be eligible for statistical analysis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anorectal Fistula
- What is being tested?
- Cook Biodesign® Fistula Plug
- Type of treatment
- Medical device
- How many people
- 79 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 30 Nov 2017to 29 Aug 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients implanted with the Cook Biodesign Fistula Plug at each of the participating institutions through 31 Dec 2016 will be included in the retrospective data collection regardless of outcome. A patient must have at least one follow-up visit.
Who may be able to join
- Patients who have had surgery to treat anorectal fistula where the Biodesign® Fistula Plug was placed during the procedure
Who cannot join
- Patients not receiving the Biodesign® Fistula Plug for treatment of their anorectal fistula
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808
University of Louisville School of Medicine
Louisville, Kentucky, 40202
University Surgical Associates
Providence, Rhode Island, 02904
About this study
Official title: A Retrospective Review of the Use of the Cook Biodesign® Fistula Plug (C-FPS-0.2, C-FPS-0.4, and C-FPS-0.7) to Treat Anorectal Fistulas
The study is a retrospective review of the use of the Biodesign® Fistula Plug (C-FPS-[X]). A total of 73 patients will be enrolled who have had a fistula plug placed to treat anorectal fistulas and will therefore be eligible for statistical analysis.
- Conditions
- Anorectal Fistula
- Being tested
- Cook Biodesign® Fistula Plug
- Keywords
- Fistula plug
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cook Biodesign® Fistula PlugDevice
The Cook Biodesign® Fistula Plug is for implantation to reinforce soft tissue for repair of Anorectal fistulas.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated for a anorectal fistula | Patients who were treated for a anorectal fistula with a Biodesign Fistula plug Receives: Device: Cook Biodesign® Fistula Plug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of fistula closure
Absence of drainage from the external fistula opening with complete epithelialization of the external fistula opening upon clinical exam.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start30 Nov 2017
- Primary completion29 Aug 2019
- Study completion29 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorectal FistulaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adal Saeed, MD, Principal investigator, St Josef's Hospital, Wiesbaden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321266
- Sponsor's protocol ID
- 17-03
- Status last verified
- Sep 2019
- First submitted
- 20 Oct 2017
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Review of the Use of the Cook Biodesign® Fistula Plug (C-FPS-0.2, C-FPS-0.4, and C-FPS-0.7) to Treat Anorectal Fistulas
- ClinicalTrials.gov ID
- NCT03321266
- Acronym / sponsor ID
- 17-03
- Conditions
- Anorectal Fistula
- Keywords
- Fistula plug
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 29 Aug 2019 (actual)
- First posted
- 25 Oct 2017 (actual)
- 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.
The study is a retrospective review of the use of the Biodesign® Fistula Plug (C-FPS-[X]). A total of 73 patients will be enrolled who have had a fistula plug placed to treat anorectal fistulas and will therefore be eligible for statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated for a anorectal fistula | – | Device: Cook Biodesign® Fistula PlugPatients who were treated for a anorectal fistula with a Biodesign Fistula plug |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients implanted with the Cook Biodesign Fistula Plug at each of the participating institutions through 31 Dec 2016 will be included in the retrospective data collection regardless of outcome. A patient must have at least one follow-up visit.
Key inclusion criteria (1 listed)
- Patients who have had surgery to treat anorectal fistula where the Biodesign® Fistula Plug was placed during the procedure
Key exclusion criteria (1 listed)
- Patients not receiving the Biodesign® Fistula Plug for treatment of their anorectal fistula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cook Biodesign® Fistula PlugThe Cook Biodesign® Fistula Plug is for implantation to reinforce soft tissue for repair of Anorectal fistulas. | Device | Patients treated for a anorectal fistula |
Primary outcome
Rate of fistula closure
Time frame: up to 2 years
Absence of drainage from the external fistula opening with complete epithelialization of the external fistula opening upon clinical exam.
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 25 Sep 2019.
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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.
Adal Saeed, MD principal investigator
St Josef's Hospital, Wiesbaden
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorectal Fistula, run by Cook Group Incorporated at 4 sites in 2 countries.
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 1 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 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Germany. 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?
Rate of fistula closure (time frame: up to 2 years). 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 25 Sep 2019.