Anal FistulaEarly Phase 1NCT02423330
A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula
A Early Phase 1 study testing Strattice-LIFT in people with Anal Fistula and Rectal Fistula, run by Rush University Medical Center at 1 site in United States.
Trial summary
This clinical trial will evaluate the safety and efficacy of the Strattice-LIFT procedure to treat anal fistulas. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Anal Fistula, Rectal Fistula, Fistula in Ano
- What is being tested?
- Strattice-LIFT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Aug 2017
- Phase
- Early Phase 1
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 22 years of age or older
- Subject is willing to comply with study related procedures
- Subject is not pregnant
- Subject has a transsphincteric fistula
- Subject is medically fit to undergo LIFT
- Subject has a draining seton for a minimum of 6 weeks
Who cannot join
- Crohn's disease
- Pelvic radiation treatment
- Known or suspected HIV/AIDS
- Known sensitivity to pork products
- Abscess or fistula etiology other than cryptoglandular
- Abdominal malignancies
Show all 13Show fewer
- Patients with <1 year life expectancy
- History of smoking
- Known anorectal dysfunction (fecal incontinence)
- Chronic use of steroids or other agents which may affect wound healing
- ASA ≥ 2
- Unable to consent to study
- Unable to complete 1 year follow up
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
This clinical trial will evaluate the safety and efficacy of the Strattice-LIFT procedure to treat anal fistulas.
Read the detailed description
The treatment of anal fistulas remains a challenging clinical problem. Fistulotomy is highly effective, but carries a significant risk of postoperative incontinence. A variety of surgical procedures that do not divide the sphincter muscle may be offered to patients, however none of them are as effective as fistulotomy.
The LIFT (ligation of intersphincteric fistula tract) procedure is a newer option for the treatment of transsphincteric fistulas. Initial results have been promising. However, some fistulas recur after the LIFT procedure because the divided ends of the fistula tract recanalize. Insertion of a barrier into the intersphincteric space may prevent this process. Strattice is acellular porcine dermis, will be used for this purpose.
This prospective trial will evaluate the safety and efficacy of the Strattice-LIFT procedure for the treatment of transsphincteric anal fistulas.
- Conditions
- Anal Fistula, Rectal Fistula, Fistula in Ano, Transsphincteric Fistula
- Being tested
- Strattice-LIFT
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strattice-LIFTDevice
Patients undergoing surgery for transsphincteric anal fistulas will undergo the Strattice-LIFT procedure. A standard LIFT procedure will be performed with the addition of Strattice placed into the intersphincteric space.
| Study group | Role | What they receive |
|---|---|---|
| Strattice-LIFT | Experimental | Not described Receives: Device: Strattice-LIFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of the anal fistula
Healing is defined as the combination of patient reported lack of drainage and surgeon reported closure of the external opening
Measured: 6 months
Secondary outcomes (3)
Healing of the anal fistula
Healing is defined as the combination of patient reported lack of drainage and surgeon reported closure of the external opening
Measured: 1 year
Postoperative Pain
Postoperative pain will be assessed at each postoperative visit with a visual analog scale
Measured: 1 year
Complications
Postoperative complications such as infection/abscess, bleeding, urinary retention, new fistula, constipation, or fecal incontinence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startSep 2014
- Primary completionAug 2017
- Study completionAug 2017
Why it stopped: Study terminated by sponsor
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.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423330
- Sponsor's protocol ID
- 14072904
- Status last verified
- Sep 2021
- First submitted
- 17 Apr 2015
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of the Strattice-LIFT to Treat Anal Fistula
- ClinicalTrials.gov ID
- NCT02423330
- Acronym / sponsor ID
- 14072904
- Conditions
- Anal Fistula, Rectal Fistula, Fistula in Ano, Transsphincteric Fistula
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated by sponsor
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 22 Apr 2015 (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.
This clinical trial will evaluate the safety and efficacy of the Strattice-LIFT procedure to treat anal fistulas.
Detailed description
The treatment of anal fistulas remains a challenging clinical problem. Fistulotomy is highly effective, but carries a significant risk of postoperative incontinence. A variety of surgical procedures that do not divide the sphincter muscle may be offered to patients, however none of them are as effective as fistulotomy.
The LIFT (ligation of intersphincteric fistula tract) procedure is a newer option for the treatment of transsphincteric fistulas. Initial results have been promising. However, some fistulas recur after the LIFT procedure because the divided ends of the fistula tract recanalize. Insertion of a barrier into the intersphincteric space may prevent this process. Strattice is acellular porcine dermis, will be used for this purpose.
This prospective trial will evaluate the safety and efficacy of the Strattice-LIFT procedure for the treatment of transsphincteric anal fistulas.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Strattice-LIFT | Experimental | Device: Strattice-LIFT |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is 22 years of age or older
- Subject is willing to comply with study related procedures
- Subject is not pregnant
- Subject has a transsphincteric fistula
- Subject is medically fit to undergo LIFT
Key exclusion criteria (13 listed)
- Crohn's disease
- Pelvic radiation treatment
- Known or suspected HIV/AIDS
- Known sensitivity to pork products
- Abscess or fistula etiology other than cryptoglandular
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 |
|---|---|---|
| Strattice-LIFTPatients undergoing surgery for transsphincteric anal fistulas will undergo the Strattice-LIFT procedure. A standard LIFT procedure will be performed with the addition of Strattice placed into the intersphincteric space. | Device | Strattice-LIFT |
Primary outcome
Healing of the anal fistula
Time frame: 6 months
Healing is defined as the combination of patient reported lack of drainage and surgeon reported closure of the external opening
3 secondary outcomes
Healing of the anal fistula
Time frame: 1 year
Postoperative Pain
Time frame: 1 year
Complications
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Study terminated by sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
Related trials for Anal Fistula
Active, not recruitingPhase 1
E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
Anal Fistula
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula
Recruiting
The Use of Electronic Bidets Compared to Water Rinsing After Surgery for Anal Fistula or Haemorrhoidal Disease: a Pilot Study
Anal Fistula Surgery, Anal Fistula
Not yet recruiting
Seton Re-routing for High Perianal Fistula
High Perianal Fistula, Fistula-in-Ano
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Strattice-LIFT in people with Anal Fistula and Rectal Fistula, run by Rush University Medical Center at 1 site 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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 14 Sep 2021. 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 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated by sponsor). Results are not available in the source record.
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?
Healing 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 14 Sep 2021; AzTrials last refreshed its copy on 8 Nov 2026.