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Tests treatment safety and results for Fecal Incontinence
Official title Evaluation of the Efficacy and Safety of Autologous Fat Injection Into the Intersphincter Space in Fecal Incontinence: a Randomized, Placebo-controlled, Cross-over, Double-blind Trial
ClinicalTrials.gov ID: NCT04972799
What this study is testing
- What it's testing
- Fecal incontinence is frequent and has a significant impact on the quality of life of individuals. Its therapeutic management is based primarily on transit regulation and rehabilitation and secondarily on neuromodulation of the sacral roots.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years of age or older
- severe fecal incontinence characterized by at least one episode of weekly fecal incontinence
- failed rehabilitation and dietary management strategies
- who have failed/contraindicated/refused sacral root neuromodulation (in the indication of fecal incontinence)
- having, for women of childbearing age, effective contraception throughout the study
You likely can't join if
- unable or unwilling to undergo follow-up or symptomatic evaluation
- contraindication to general anesthesia
- contraindication to metronidazole (hypersensitivity and wheat allergy)
- significant pelvic static disorder
- active anal suppuration
- anal stenosis
See the full eligibility criteria
- 18 years of age or older
- severe fecal incontinence characterized by at least one episode of weekly fecal incontinence
- failed rehabilitation and dietary management strategies
- who have failed/contraindicated/refused sacral root neuromodulation (in the indication of fecal incontinence)
- having, for women of childbearing age, effective contraception throughout the study
- having given free, informed and written consent
- unable or unwilling to undergo follow-up or symptomatic evaluation
- contraindication to general anesthesia
- contraindication to metronidazole (hypersensitivity and wheat allergy)
- significant pelvic static disorder
- active anal suppuration
- anal stenosis
- externalized rectal prolapse
- chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis)
- on anticoagulants or antiaggregants
- history of anal or rectal neoplasia
- coagulation anomaly, curative anticoagulation
- history of rectal surgery
- history of pelvic radiotherapy
- previous treatment with inert materials (hyaluronic acid, biosilicones, coaptitis) in the 5 years preceding inclusion
- allergy to lidocaine or contraindication to adrenaline
- protected person (adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty, pregnant or breast-feeding woman, minor)
- participating in another treatment trial concurrently
- not covered by a social security system
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Nantes, France
- Rennes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Nantes, France; Rennes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.