Fecal IncontinenceNCT05708612
Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)
A study testing Medical Device (SimplyFI) in people with Fecal Incontinence, run by A.M.I. Agency for Medical Innovations GmbH at 5 sites in 3 countries.
Trial summary
The purpose of the clinical investigation is to verify that the device under investigation (SimplyFI) is appropriate to significantly improve fecal incontinence in patients in whom its use is indicated. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Medical Device (SimplyFI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 1 Apr 2023to 28 Oct 2026
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female subjects
- Age ≥ 18 years, <85 years
- Subject has failed standard conservative therapy for fecal incontinence (at least 6 months)
- 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
- Treatment with another investigational drug or investigational device
- Unable to understand study requirements or is unable to comply with follow-up schedule
- Contraindicated according to the instruction for use of the device
- Pregnancy or nursing, or plans to become pregnant
- History of significant obstructed defecation or other significant chronic defecatory motility disorders
- Current, external full thickness rectal prolapse or vaginal prolapse
Show all 17Show fewer
- Inflammatory Bowel Disease
- Irritable Bowel Syndrome
- Systemic disease as source of FI (scleroderma, neurologic disorders, Crohn's)
- Active pelvic infection
- Chronic diarrhea
- Medical history of anal, rectal, or colon cancer
- Prior anterior resection of the rectum
- Medical history of pelvic radiation therapy
- Significant scarring of the recto-vaginal septum, a permanent implant in the rectovaginal septum, or a history of recto-vaginal fistula
- Previous anorectal posterior compartment surgery
- History of complex anal fistula
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Austria2 sites
Göttlicher Heiland Krankenhaus
Vienna
Medical University Vienna
Vienna
Spain2 sites
Hospital Ruber Internacional
Madrid
Hospital Universitario Ramón y Cajal
Madrid
About this study
The purpose of the clinical investigation is to verify that the device under investigation (SimplyFI) is appropriate to significantly improve fecal incontinence in patients in whom its use is indicated.
- Conditions
- Fecal Incontinence
- Being tested
- Medical Device (SimplyFI)
- Keywords
- Surgical Treatment, Implant
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Device (SimplyFI)Procedure or surgery
Implantation a non-active medical device (SimplyFI) for the treatment of chronic fecal incontinence.
| Study group | Role | What they receive |
|---|---|---|
| Implantation of SimplyFI | Experimental | Long-term non-active implant Receives: Procedure: Medical Device (SimplyFI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety-related complications and adverse events
The primary endpoint is safety-related complications and adverse events during follow-up until 12 months after surgery.
Measured: 12 months
Secondary outcomes (2)
Cure of fecal incontinence (Fecal Incontinence Quality of Life Scale (FIQLs))
The secondary endpoint is to evaluate the change of fecal incontinence assessed by validated scores (changes from baseline to 1 week, 1 months, 3 months, 6 months) until 12 months after surgery.
Fecal Incontinence Quality of Life scale (all subscale scores 1-4). Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. Scale scores are the average (mean) response to all items in the scale.
Measured: 12 months
Quality of Life (St. Mark's incontinence score (SMIS))
The secondary endpoint is to evaluate the change of Quality of Life assessed by validated scores (changes from baseline to 1 week, 1 months, 3 months, 6 months) until 12 months after surgery.
St. Marks incontinence score contains 7 questions, and a higher total score means a worse outcome
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 posted1 Feb 2023
- Study start1 Apr 2023
- Primary completion28 Mar 2026
- Study completion28 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.M.I. Agency for Medical Innovations GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Riss, Prof. PD Dr., Principal investigator, Medical University of ViennaJosé Manuel Devesa Múgica, Dr., Principal investigator, Hospital Ruber Internacional
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708612
- Sponsor's protocol ID
- CI-48-001
- Other IDs
- CIV-AT-23-01-041926
- Status last verified
- Oct 2026
- First submitted
- 23 Jan 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dawoud C, Devesa JM, Lohnert M, Vicente R, Metwalli SA, Riss S. Artificial sphincter with a new silicone band for treating faecal incontinence: IDEAL 2b prospective multicentre trial. BJS Open. 2025 Sep 8;9(5):zraf112. doi: 10.1093/bjsopen/zraf112.
PubMed 41123163
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)
- ClinicalTrials.gov ID
- NCT05708612
- Acronym / sponsor ID
- CI-48-001
- Conditions
- Fecal Incontinence
- Keywords
- Surgical Treatment, Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- A.M.I. Agency for Medical Innovations GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 28 Mar 2026 (actual)
- Study completion
- 28 Oct 2026 (actual)
- First posted
- 1 Feb 2023 (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 purpose of the clinical investigation is to verify that the device under investigation (SimplyFI) is appropriate to significantly improve fecal incontinence in patients in whom its use is indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation of SimplyFI | Experimental | Procedure: Medical Device (SimplyFI)Long-term non-active implant |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Both male and female subjects
- Age ≥ 18 years, <85 years
- Subject has failed standard conservative therapy for fecal incontinence (at least 6 months)
- Subject is a surgical candidate
- Subject is willing and able to cooperate with follow-up examinations
Key exclusion criteria (17 listed)
- Treatment with another investigational drug or investigational device
- Unable to understand study requirements or is unable to comply with follow-up schedule
- Contraindicated according to the instruction for use of the device
- Pregnancy or nursing, or plans to become pregnant
- History of significant obstructed defecation or other significant chronic defecatory motility disorders
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 |
|---|---|---|
| Medical Device (SimplyFI)Implantation a non-active medical device (SimplyFI) for the treatment of chronic fecal incontinence. | Procedure or surgery | Implantation of SimplyFI |
Primary outcome
Safety-related complications and adverse events
Time frame: 12 months
The primary endpoint is safety-related complications and adverse events during follow-up until 12 months after surgery.
2 secondary outcomes
Cure of fecal incontinence (Fecal Incontinence Quality of Life Scale (FIQLs))
Time frame: 12 months
Quality of Life (St. Mark's incontinence score (SMIS))
Time frame: 12 months
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 30 Oct 2026.
- Results publication: PubMed 41123163Dawoud C, Devesa JM, Lohnert M, Vicente R, Metwalli SA, Riss S. Artificial sphincter with a new silicone band for treating faecal incontinence: IDEAL 2b prospective multicentre trial. BJS Open. 2025 Sep 8;9(5):zraf112. doi: 10.1093/bjsopen/zraf112.
- Individual participant dataSharing planned: No
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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.
Stefan Riss, Prof. PD Dr. principal investigator
Medical University of Vienna
José Manuel Devesa Múgica, Dr. principal investigator
Hospital Ruber Internacional
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Device (SimplyFI) in people with Fecal Incontinence, run by A.M.I. Agency for Medical Innovations GmbH at 5 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 6 inclusion and 17 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 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Austria, Spain, 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?
Safety-related complications and adverse events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05708612, which also lists 1 linked publication.
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 30 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.