Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Göttlicher Heiland Krankenhaus, Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical Device (SimplyFI)

Procedure

Implantation a non-active medical device (SimplyFI) for the treatment of chronic fecal incontinence.

Primary outcomes

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.

Secondary outcomes

Cure of fecal incontinence (Fecal Incontinence Quality of Life Scale (FIQLs))

Time frame: 12 months

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.
Quality of Life (St. Mark's incontinence score (SMIS))

Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

A.M.I. Agency for Medical Innovations GmbH

Industry

Registry information

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Feb 1, 2023
Registry last updated: Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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