Anal Fistula
Conditions
Brief summary
Primary outcome variable is healing at the final follow up visit.
Detailed description
The primary purpose of this prospective, multicenter, observational, single arm study is to further substantiate efficacy of the GORE® BIO-A® Fistula Plug when used as a soft tissue reinforcement of anal fistula repair and healing.
Interventions
DEVICEFistula Plug
Bioabsorbable fistula plug
Sponsors
W.L.Gore & Associates
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Transsphincteric fistula consisting of 1 tract(defined as a fistula which would not be amenable to fistulotomy); determined during operative procedure * Likely cryptoglandular origin * Must be at least 18 years of age * Patients informed about the study, and will have read, understood and signed the patient informed consent and authorization to use PHI data, as applicable * Patients willing and able to submit to postoperative follow-up evaluations
Exclusion criteria
* Crohn's Disease * Evidence of on-going local infection * History of more than 2 prior definitive repair attempts; repair attempt is defined as any of the following: advancement flap, cutting seton, fistulotomy, fistulectomy, fibrin glue, anal fistula plug, LIFT * Superficial fistulas without any muscle involvement * Fistulae of traumatic origin, including obstetric * Intersphincteric fistulas that would be candidate for fistulotomy * Horseshoe or multi-tract fistulas * Ano-vaginal or recto-vaginal fistulas * Anastomotic fistulas (ileo-anal, colo-anal) * A wound-healing or autoimmune disorder (including insulin-dependent diabetics) * Subjects who are immunocompromised such as, with HIV, or currently receiving chemo or radiation therapy * Subjects who are immunosuppressed, e.g. transplant patients, patients taking steroids, TNF agents, methotrexate * History of prior or current pelvic radiation * Difficulty comprehending or complying with the study (in surgeon's opinion)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fistula Closure | 12 months post procedure |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Drainage Post Procedure | Follow up out to 12 months post procedure |
Participant flow
Recruitment details
A total of 93 subjects were recruited from 11 sites between March of 2011 and September 2013.
Participants by arm
| Arm | Count |
|---|---|
| GORE® BIO-A® Fistula Plug All patients in study receive the GORE® BIO-A® Fistula Plug.
Fistula Plug: Bioabsorbable fistula plug | 93 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Early Termination of Study | 4 |
| Overall Study | Lost to Follow-up | 11 |
| Overall Study | Withdrawal by Subject | 23 |
Baseline characteristics
| Characteristic | GORE® BIO-A® Fistula Plug |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 80 Participants |
| Gender Female | 22 Participants |
| Gender Male | 71 Participants |
| Region of Enrollment United States | 93 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 45 / 93 |
| serious Total, serious adverse events | 0 / 93 |
Outcome results
Primary
Fistula Closure
Time frame: 12 months post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE® BIO-A® Fistula Plug | Fistula Closure | 35 participants |
Secondary
Duration of Drainage Post Procedure
Time frame: Follow up out to 12 months post procedure