Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)
NCT ID: NCT05708612
Last Updated: 2025-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36 participants
INTERVENTIONAL
2023-04-01
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Implantation of SimplyFI
Long-term non-active implant
Medical Device (SimplyFI)
Implantation a non-active medical device (SimplyFI) for the treatment of chronic fecal incontinence.
Interventions
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Medical Device (SimplyFI)
Implantation a non-active medical device (SimplyFI) for the treatment of chronic fecal incontinence.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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A.M.I. Agency for Medical Innovations GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Stefan Riss, Prof. PD Dr.
Role: PRINCIPAL_INVESTIGATOR
Medical University Vienna
José Manuel Devesa Múgica, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital Ruber Internacional
Locations
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Göttlicher Heiland Krankenhaus
Vienna, , Austria
Medical University Vienna
Vienna, , Austria
Klinikum Bielefeld Rosenhöhe
Bielefeld, , Germany
MVZ Wiesbaden / KD Helios Klinik
Wiesbaden, , Germany
Hospital Ruber Internacional
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Countries
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Central Contacts
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A.M.I. Agency for Medical Innovations (Clinical Affairs)
Role: CONTACT
Facility Contacts
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Michaela Lechner, Dr.in
Role: primary
Stefan Riss, Prof. PD Dr.
Role: primary
Mathias Löhnert, Prof. Dr.
Role: primary
José Manuel Devesa Múgica, Dr.
Role: primary
Araceli Bellestro Pérez, Dra.
Role: primary
References
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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.
Other Identifiers
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CIV-AT-23-01-041926
Identifier Type: OTHER
Identifier Source: secondary_id
CI-48-001
Identifier Type: -
Identifier Source: org_study_id
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