Anal FistulaLIFT+GraftNCT01602081
Ligation of the Intersphincteric Fistula Tract (LIFT) + Biodesign for Anal Fistula
An observational study of Anal Fistula, run by Cook Group Incorporated at 8 sites in United States.
Trial summary
The LIFT+Biodesign® study is a post-market observational study to evaluate the rate of fistula closure in patients with persistent trans-sphincteric anal fistula who receive the Biodesign® Tissue graft as part of their LIFT procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fistula
- What is being tested?
- reinforce soft tissue
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 8 sitesUnited States
- Study dates
- Jan 2013to Jan 2015
- 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: Regional and Community Hospitals
Who may be able to join
- Persistent primary or recurrent trans-sphincteric anal fistula
Who cannot join
- Patients with prior fistulotomy, fistulectomy, LIFT, cutting seton or advancement flap procedure
- Fistula with multiple tracts
- Recto-vaginal fistula
- Active infection in the anal fistula
- Physical allergies or cultural objections to porcine products
- Patient is not medically fit to undergo the LIFT procedure as judged by the treating physician
- Previous diagnosis of collagen disorder
- History of Crohn's Disease, Irritable Bowel Syndrome, radiation therapy in the rectoanal region
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Rush University Medical Center
Chicago, Illinois, 60612
Case Medical Center
Cleveland, Ohio, 44106
Indiana University Hospitals
Indianapolis, Indiana, 46202
Kendrick Regional Center
Indianapolis, Indiana, 46237
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Mount Sinai Hospital
New York, New York, 10021
University of California Irvine
Orange, California, 92868
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19106
About this study
Official title: Ligation of the Intersphincteric Fistula Tract With Tissue Graft Placement for Treatment of Persistent Trans-sphincteric Anal Fistula
The LIFT+Biodesign® study is a post-market observational study to evaluate the rate of fistula closure in patients with persistent trans-sphincteric anal fistula who receive the Biodesign® Tissue graft as part of their LIFT procedure.
- Conditions
- Anal Fistula
- Being tested
- reinforce soft tissue
- Keywords
- Anal fistula, Ligation of the intersphincteric fistula tract, LIFT, Tissue graft
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reinforce soft tissueDevice
reinforce soft tissue
| Study group | Role | What they receive |
|---|---|---|
| LIFT+Biodesign | Not described Receives: Device: reinforce soft tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure of the anal fistula
Measured: 6 months
Secondary outcomes (1)
Closure of the anal fistula
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal 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
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602081
- Sponsor's protocol ID
- 10-012
- Acronym
- LIFT+Graft
- Status last verified
- Feb 2015
- First submitted
- 16 May 2012
- Last updated
- 11 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ligation of the Intersphincteric Fistula Tract With Tissue Graft Placement for Treatment of Persistent Trans-sphincteric Anal Fistula
- ClinicalTrials.gov ID
- NCT01602081
- Acronym / sponsor ID
- LIFT+Graft / 10-012
- Conditions
- Anal Fistula
- Keywords
- Anal fistula, Ligation of the intersphincteric fistula tract, LIFT, Tissue graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 May 2012 (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.
The LIFT+Biodesign® study is a post-market observational study to evaluate the rate of fistula closure in patients with persistent trans-sphincteric anal fistula who receive the Biodesign® Tissue graft as part of their LIFT procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LIFT+Biodesign | – | Device: reinforce soft tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Regional and Community Hospitals
Key inclusion criteria (1 listed)
- Persistent primary or recurrent trans-sphincteric anal fistula
Key exclusion criteria (8 listed)
- Patients with prior fistulotomy, fistulectomy, LIFT, cutting seton or advancement flap procedure
- Fistula with multiple tracts
- Recto-vaginal fistula
- Active infection in the anal fistula
- Physical allergies or cultural objections to porcine products
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 |
|---|---|---|
| reinforce soft tissuereinforce soft tissue | Device | LIFT+Biodesign |
Primary outcome
Closure of the anal fistula
Time frame: 6 months
1 secondary outcome
Closure of the anal fistula
Time frame: 12 months
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 11 Feb 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Fistula, run by Cook Group Incorporated at 8 sites in United States.
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 8 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 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
Closure of the anal fistula (time frame: 6 months). 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 11 Feb 2015.