Fecal Incontinence
Conditions
Keywords
FENIX
Brief summary
The purpose of this feasibility study is to obtain preliminary safety and effectiveness information and develop procedural optimization for the Magnetic Anal Sphincter device (FENIX System) in reinforcement of anal sphincter function to treat severe fecal incontinence (FI).
Detailed description
Study subjects followed to 12 months post implant outside the U.S. Study subjects followed to 5 years post implant in the U.S.
Interventions
DEVICEMagnetic Anal Sphincter
The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.
Sponsors
Torax Medical Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 19 years, \<85 years, life expectancy \>3yrs. * Documented history of severe fecal incontinence for at least 6 months * Subject diary documents ≥ 2 episodes per week on average over diary period, leakage greater than seepage * Subject has failed standard conservative and medical therapy * Subject is a surgical candidate. * Subject is willing and able to cooperate with follow-up examinations. * Subject has been informed of the study procedures and the treatment and has signed an informed consent form and provided authorization to use and disclose information for research purposes.
Exclusion criteria
* Subject has history of significant obstructed defecation or other significant chronic defecatory motility disorders * Subject has current, external full thickness rectal prolapse or vaginal prolapse * Subject has an electric or metallic implant within 10cm of the area of device placement * Subject has Inflammatory Bowel Disease * Subject has Irritable Bowel Syndrome * Subject has systemic disease as source of FI (scleroderma, neurologic disorders, Crohn's) * Subject has active pelvic infection * Subject has chronic diarrhea * Subject diagnosed with anal, rectal, or colon cancer within 2 years * Subject has had prior anterior resection of the rectum * Subject has undergone pelvic radiation therapy * Subject has significant scarring of the recto-vaginal septum, a permanent implant in the recto-vaginal septum, or a history of recto-vaginal fistula * Subject has had previous anorectal posterior compartment surgery * The procedure is an emergency procedure * Subject is currently being treated with another investigational drug or investigational device. * Subject cannot understand trial requirements or is unable to comply with follow-up schedule. * Subject is pregnant or nursing, or plans to become pregnant. * Subject has history of complex anal fistula
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 60 months | The safety objective will be met via reporting all adverse events at various time points including implant, 6 weeks, 3 months, 6 months, and 12 months (and then semi-annually until 5 years post-implant at U.S. sites). Serious device- and procedure-related adverse events will be summarized separately. Safety will be characterized by physical examination and pelvic X-ray evaluations. |
| Reduction in Fecal Incontinence Symptoms | 12 Months | Effectiveness will be characterized as the reduction of FI symptoms by subjective measurements using the FISI, Wexner, and FIQOL scores and a three week diary documenting episodes of incontinence. |
Countries
Denmark, France, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Magnetic Anal Sphincter Augmentation The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.
Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision. | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Magnetic Anal Sphincter Augmentation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 64.1 years STANDARD_DEVIATION 9.7 |
| Fecal incontinence episodes | 13.9 episodes per week STANDARD_DEVIATION 6.7 |
| Region of Enrollment Denmark | 5 participants |
| Region of Enrollment France | 15 participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 35 |
| serious Total, serious adverse events | 6 / 35 |
Outcome results
Primary
Adverse Events
The safety objective will be met via reporting all adverse events at various time points including implant, 6 weeks, 3 months, 6 months, and 12 months (and then semi-annually until 5 years post-implant at U.S. sites). Serious device- and procedure-related adverse events will be summarized separately. Safety will be characterized by physical examination and pelvic X-ray evaluations.
Time frame: 60 months
Population: All adverse events as reported by investigators
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Magnetic Anal Sphincter Augmentation | Adverse Events | All Adverse Events | 223 Number of events |
| Magnetic Anal Sphincter Augmentation | Adverse Events | Serious Device or Procedure-related Adverse Events | 7 Number of events |
Primary
Reduction in Fecal Incontinence Symptoms
Effectiveness will be characterized as the reduction of FI symptoms by subjective measurements using the FISI, Wexner, and FIQOL scores and a three week diary documenting episodes of incontinence.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Magnetic Anal Sphincter Augmentation | Reduction in Fecal Incontinence Symptoms | 3.8 episodes per week | Standard Deviation 5.1 |