NCT05708612

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
3 countries

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Apr 2023Sep 2026

First Submitted

Initial submission to the registry

January 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

January 23, 2023

Last Update Submit

March 18, 2026

Conditions

Fecal Incontinence

Keywords

Surgical TreatmentImplant

Outcome Measures

Primary Outcomes (1)

  • Safety-related complications and adverse events

    The primary endpoint is safety-related complications and adverse events during follow-up until 12 months after surgery.

    12 months

Secondary Outcomes (2)

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

    12 months

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

    12 months

Study Arms (1)

Implantation of SimplyFI

EXPERIMENTAL

Long-term non-active implant

Procedure: Medical Device (SimplyFI)

Interventions

Medical Device (SimplyFI)PROCEDURE

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

Implantation of SimplyFI

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Göttlicher Heiland Krankenhaus

Vienna, Austria

Location

Medical University Vienna

Vienna, Austria

Location

Klinikum Bielefeld Rosenhöhe

Bielefeld, Germany

Location

Hospital Ruber Internacional

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Related Publications (1)

  • 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.

    PMID: 41123163RESULT

MeSH Terms

Conditions

Fecal Incontinence

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Stefan Riss, Prof. PD Dr.

    Medical University Vienna

    PRINCIPAL INVESTIGATOR

  • José Manuel Devesa Múgica, Dr.

    Hospital Ruber Internacional

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2023

First Posted

February 1, 2023

Study Start

April 1, 2023

Primary Completion

April 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)ES(2)AU(2)