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

Launched by A.M.I. AGENCY FOR MEDICAL INNOVATIONS GMBH · Jan 23, 2023

Keywords

ClinConnect Summary

This clinical trial, called SimplyFI, is studying the safety and effectiveness of a new silicone implant designed to help treat fecal incontinence, which is the inability to control bowel movements. The goal is to see if this implant can significantly improve the condition for patients who have not had success with other standard treatments for at least six months. The trial is currently looking for participants aged 18 to 85, and both men and women are welcome to join. To be eligible, individuals need to be surgical candidates and willing to attend follow-up appointments.

If you decide to participate, you will receive the new device and be closely monitored throughout the study to track your progress. Before joining, you will need to give your informed consent, which means you will be fully informed about the study and agree to participate. However, certain medical conditions or previous treatments may disqualify you from joining, such as having a history of specific bowel diseases or previous surgeries related to the rectum. Overall, this study aims to provide new hope for those struggling with fecal incontinence by exploring a potential treatment option.

Gender

ALL

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