Status:
UNKNOWN
Safety and Effectiveness Evaluation of the ForConti Contix Fecal Incontinence Management System (FIMS)
Lead Sponsor:
ForConti Medical
Conditions:
Fecal Incontinence
Eligibility:
All Genders
22-85 years
Phase:
NA
Brief Summary
The ForConti Contix Fecal Incontinence Management System (FIMS) is indicated for the management of accidental bowel leakage due to bowel incontinence. The ForConti Contix FIMS is designed to seal and ...
Detailed Description
Treatments for bowel incontinence depend on the cause and severity of the condition. Often more than one modality is used to treat the condition, beginning with conservative options such as adult diap...
Eligibility Criteria
Inclusion
- Patient has signed the informed consent form and is willing to participate in the clinical study. Patient has the ability to self-manage insertion and removal of the device
- Patient age is between 22 and 85 years old
- Patient has history of fecal incontinence for at least 6 months
- Patient has a minimum of four incontinence episodes during the 2-week baseline period
- Patient colon surveillance complies with National Program/Guidelines for the Early Detection of Colorectal Cancer
- Patient comprehends study meaning and is capable of carrying out study duties
- If the candidate is currently prescribed medication per os or per rectum for bowel control, treatment has been administered for at least 4 weeks without a change in treatment regimen or dose, and the candidate agrees to continue the treatment without changes for the duration of the study
Exclusion
- Patient had spinal cord injury or other major neurological diagnosis
- Patient has known life threatening disease such as cancer, immune deficiency state
- Patient has significant cardiac arrhythmia\*
- Patient has inflammatory bowel disease
- Patient is on anti-coagulants and anti-platelets treatment, except Aspirin (low dose: 75-100 mg/day)
- Patient has anorectal disease: perianal abscess, active fistula, fissure, hemorrhoids grade 3 or 4, Pruritus ani or rectal bleeding\*
- Patient has a clinically significant abnormality as visualized by sigmoidoscopy at the first visit
- Patient has pre-existing rectal pain or rectal bleeding
- Patient suffers from chronic pelvic pain
- Patient had rectal surgery in the past 6 months
- Patient has rectocele or other pelvic organ prolapse requiring surgery\*
- Patient has allergy to silicone or one of its components
- Patient has significant medical condition which may interfere with study participation
- Patient is currently participating in another clinical study.
- Female patient is pregnant or breastfeeding
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03813251
Start Date
February 1 2019
End Date
August 1 2019
Last Update
January 23 2019
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.