Fecal IncontinenceNCT01625221
Feasibility Study of the Magnetic Anal Sphincter (FENIX System)
A study testing Magnetic Anal Sphincter in people with Fecal Incontinence, run by Torax Medical Incorporated at 4 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 84 years
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Magnetic Anal Sphincter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Dec 2008to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Colon and Rectal Surgery Associates
Minneapolis, Minnesota
Providence Medical Research Center
Spokane, Washington, 99204
About this study
Official title: An Observational Clinical Feasibility Study of The Magnetic Anal Sphincter
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).
Read the 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.
- Conditions
- Fecal Incontinence
- Being tested
- Magnetic Anal Sphincter
- Keywords
- FENIX
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Anal SphincterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic anal sphincter augmentation | Experimental | 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. Receives: Device: Magnetic Anal Sphincter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 months
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.
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 posted21 Jun 2012 (estimated)
- Study startDec 2008
- Primary completionMar 2012
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fecal IncontinenceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Torax Medical Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625221
- Sponsor's protocol ID
- 1876, 1990, 2321
- Status last verified
- Dec 2017
- First submitted
- 19 Jun 2012
- Last updated
- 3 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Clinical Feasibility Study of The Magnetic Anal Sphincter
- ClinicalTrials.gov ID
- NCT01625221
- Acronym / sponsor ID
- 1876, 1990, 2321
- Conditions
- Fecal Incontinence
- Keywords
- FENIX
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Torax Medical IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 21 Jun 2012 (estimated)
- Results
- Posted 13 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic anal sphincter augmentation | Experimental | Device: Magnetic Anal SphincterThe 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. |
Who may qualify
- Ages
- 19 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
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 |
|---|---|---|
| Magnetic Anal SphincterThe 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. | Device | Magnetic anal sphincter augmentation |
Primary outcome
Adverse Events
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Anal Sphincter in people with Fecal Incontinence, run by Torax Medical Incorporated at 4 sites in 3 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 7 inclusion and 18 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 3 Jan 2018. 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, Denmark, France. 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?
Yes. Results are posted in the registry (first posted 13 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adverse Events (time frame: 60 months). The study lists 2 primary outcomes in all. 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 3 Jan 2018.