Fecal IncontinenceNCT04007250
FENIX™ Continence Restoration System Registry
An observational study of Fecal Incontinence and Faecal Incontinence, run by Torax Medical Incorporated at 2 sites in 2 countries.
Trial summary
The FENIX Registry is a multi-center, observational database designed to collect data regarding the FENIX™ Continence Restoration System in everyday clinical practice, evaluate the clinical course of patients from pre-operative assessment through five years post-surgery and Track and monitor effectiveness and safety… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fecal Incontinence, Faecal Incontinence
- What is being tested?
- FENIX™ Continence Restoration System
- Type of treatment
- Medical device
- How many people
- 94 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Jan 2012to 27 Feb 2019
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Chronic fecal incontinence patients who have failed or are not candidates for more conservative therapy.
Who may be able to join
- Individuals being treated with the FENIX™ Continence Restoration System
- Individuals who have provided appropriate authorization per institutional policy and procedure to have clinical and health information collected for the FENIX Registry.
- Individuals willing to complete a 14-day bowel diary, questionnaires and comply with all required follow-up.
Who cannot join
- Known circumstances that would make it unlikely for an individual to complete the five-year follow-up (e.g. life expectancy <5 years)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The FENIX Registry is a multi-center, observational database designed to collect data regarding the FENIX™ Continence Restoration System in everyday clinical practice, evaluate the clinical course of patients from pre-operative assessment through five years post-surgery and Track and monitor effectiveness and safety through the use of a bowel diary, fecal incontinence quality-of-life measures and adverse event reporting. Up to 25 sites will participate in the Registry. Sites to enroll consecutive eligible patients into the Registry. Registry will enroll approximately 200 FENIX patients.
- Conditions
- Fecal Incontinence, Faecal Incontinence
- Being tested
- FENIX™ Continence Restoration System
- Keywords
- Magnetic Anal Sphincter Augmentation, FENIX™ continence restoration system, Magnetic Anal Sphincter
- Medical subject headings
- Fecal Incontinence, Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FENIX™ Continence Restoration SystemDevice
Also called Magnetic anal sphincter augmentation
The FENIX™ Continence Restoration System is indicated for use for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative therapy. The FENIX™ System Implant is placed around the external anal sphincter to augment a weak anal sphincter and restore continence.
The FENIX™ System is comprised of the following components:
- FENIX™ System Implant
- FENIX™ System Anal Sphincter Sizing Tool The FENIX™ System Implant consists of a series of titanium beads with magnetic cores that are connected with independent titanium wires to form an annular shape. The attractive force of the magnetic beads is designed to provide additional strength to keep a weak anal sphincter closed.
| Study group | Role | What they receive |
|---|---|---|
| FENIX participants | Individuals being treated with the FENIX™ Continence Restoration System. Receives: Device: FENIX™ Continence Restoration System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fecal incontinence (FI) episodes
Proportion of participants with at least a 50% reduction in FI episodes per week
Measured: Evaluate at 6 months and then annually at 12 months through 60 months post implant
Change in fecal incontinence days
Proportion of participants achieving at least 50% reduction in FI days per week and urgent episodes
Measured: Evaluate at 6 months and then annually at 12 months through 60 months post implant
Adverse events related to the FENIX system
From the time of implant and at each follow-up visit, safety will be evaluated by characterizing adverse events (AEs) related to the FENIX system and summarizing incidence rates. Serious device-related AEs will be summarized separately.
Measured: assessed up to last follow up [max 60 months]
Change in Fecal Incontinence Quality of Life: Fecal Incontinence Quality of Life (FIQOL) score.
Proportion of patients with improvement in Fecal Incontinence Quality of Life (FIQOL) score. The Fecal Incontinence Quality of Life Scale consists of 29 items divided into 4 scales:
- Lifestyle (10 items)
- Coping/Behavior (9 items)
- Depression/Self Perception (7 items)
- Embarrassment (3 items) Scales range from 1 to 5, scale scores are the average (mean) of all responses to all items in each scale. A lower score indicated a lower quality of life. The scales are not combined for a "composite" or total score but always presented individually.
Measured: Evaluate at 6 months and then annually at 12 months through 60 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start7 Jan 2012
- Primary completion27 Feb 2019
- Study completion27 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Torax Medical Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007250
- Sponsor's protocol ID
- 3422
- Status last verified
- Jul 2019
- First submitted
- 27 Jun 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FENIX™ Continence Restoration System Registry
- ClinicalTrials.gov ID
- NCT04007250
- Acronym / sponsor ID
- 3422
- Conditions
- Fecal Incontinence, Faecal Incontinence
- Keywords
- Magnetic Anal Sphincter Augmentation, FENIX™ continence restoration system, Magnetic Anal Sphincter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Torax Medical IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2012 (actual)
- Primary completion
- 27 Feb 2019 (actual)
- Study completion
- 27 Feb 2019 (actual)
- First posted
- 5 Jul 2019 (actual)
- 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 FENIX Registry is a multi-center, observational database designed to collect data regarding the FENIX™ Continence Restoration System in everyday clinical practice, evaluate the clinical course of patients from pre-operative assessment through five years post-surgery and Track and monitor effectiveness and safety through the use of a bowel diary, fecal incontinence quality-of-life measures and adverse event reporting. Up to 25 sites will participate in the Registry. Sites to enroll consecutive eligible patients into the Registry. Registry will enroll approximately 200 FENIX patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FENIX participants | – | Device: FENIX™ Continence Restoration SystemIndividuals being treated with the FENIX™ Continence Restoration System. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Chronic fecal incontinence patients who have failed or are not candidates for more conservative therapy.
Key inclusion criteria (3 listed)
- Individuals being treated with the FENIX™ Continence Restoration System
- Individuals who have provided appropriate authorization per institutional policy and procedure to have clinical and health information collected for the FENIX Registry.
- Individuals willing to complete a 14-day bowel diary, questionnaires and comply with all required follow-up.
Key exclusion criteria (1 listed)
- Known circumstances that would make it unlikely for an individual to complete the five-year follow-up (e.g. life expectancy <5 years)
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 |
|---|---|---|
| FENIX™ Continence Restoration SystemAlso: Magnetic anal sphincter augmentationThe FENIX™ Continence Restoration System is indicated for use for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative therapy. The FENIX™ System Implant is placed around the external anal sphincter to augment a weak anal sphincter and restore continence. The FENIX™ System is comprised of the following components: * FENIX™ System Implant * FENIX™ System Anal Sphincter Sizing Tool The FENIX™ System Implant consists of a series of titanium beads with magnetic cores that are connected with independent titanium wires to form an annular shape. The attractive force of the magnetic beads is designed to provide additional strength to keep a weak anal sphincter closed. | Device | FENIX participants |
Primary outcome
Change in fecal incontinence (FI) episodes
Time frame: Evaluate at 6 months and then annually at 12 months through 60 months post implant
Proportion of participants with at least a 50% reduction in FI episodes per week
Change in fecal incontinence days
Time frame: Evaluate at 6 months and then annually at 12 months through 60 months post implant
Proportion of participants achieving at least 50% reduction in FI days per week and urgent episodes
Adverse events related to the FENIX system
Time frame: assessed up to last follow up [max 60 months]
From the time of implant and at each follow-up visit, safety will be evaluated by characterizing adverse events (AEs) related to the FENIX system and summarizing incidence rates. Serious device-related AEs will be summarized separately.
Change in Fecal Incontinence Quality of Life: Fecal Incontinence Quality of Life (FIQOL) score.
Time frame: Evaluate at 6 months and then annually at 12 months through 60 months post implant
Proportion of patients with improvement in Fecal Incontinence Quality of Life (FIQOL) score. The Fecal Incontinence Quality of Life Scale consists of 29 items divided into 4 scales: * Lifestyle (10 items) * Coping/Behavior (9 items) * Depression/Self Perception (7 items) * Embarrassment (3 items) Scales range from 1 to 5, scale scores are the average (mean) of all responses to all items in each scale. A lower score indicated a lower quality of life. The scales are not combined for a "composite" or total score but always presented individually.
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 26 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Fecal Incontinence
Not yet recruitingObservational study
Fecal Incontinence (FI) is a Debilitating Physical and Psychological Disorder Characterizedbytheinvoluntary Loss of Flatus or Liquid/Solid Stool.
MRI in Evaluation of Fecal Incontinence
Active, not recruitingPhase 2/3
The Safety and Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Fecal Incontinence
Fecal Incontinence
Not yet recruiting
Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
Faecal Incontinence With Faecal Urgency, Rectal Cancer
Active, not recruitingPhase 3
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
Fecal Incontinence
Recruiting
Aquarius Pilot Study to Evaluate the New Axonics Trial System
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fecal Incontinence and Faecal Incontinence, run by Torax Medical Incorporated at 2 sites in 2 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 3 inclusion and 1 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 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Germany. 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?
Change in fecal incontinence (FI) episodes (time frame: Evaluate at 6 months and then annually at 12 months through 60 months post implant). The study lists 4 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 26 Jul 2019.