Clinical trial NCT05708612: Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)
Official title: Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fecal Incontinence
Keywords: Surgical Treatment
Implant
Lead sponsor: A.M.I. Agency for Medical Innovations GmbH
Sponsor class: INDUSTRY
First posted: 2023-02-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Safety-related complications and adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Cure of fecal incontinence (Fecal Incontinence Quality of Life Scale (FIQLs))
timeFrame: 12 months
measure: Quality of Life (St. Mark's incontinence score (SMIS))
timeFrame: 12 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Göttlicher Heiland Krankenhaus
city: Vienna
country: Austria
facility: Medical University Vienna
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld Rosenhöhe
city: Wiesbaden
country: Germany
facility: MVZ Wiesbaden / KD Helios Klinik
city: Madrid
country: Spain
facility: Hospital Ruber Internacional
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
affiliation: Medical University Vienna
name: Stefan Riss, Prof. PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Ruber Internacional
name: José Manuel Devesa Múgica, Dr.
role: PRINCIPAL_INVESTIGATOR
References: