Fecal IncontinenceNCT03813251
Safety and Effectiveness Evaluation of the ForConti Contix Fecal Incontinence Management System (FIMS)
A study testing ForConti Contix Fecal Incontinence Management System (FIMS) in people with Fecal Incontinence, run by ForConti Medical.
Trial 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 help prevent the involuntary leakage of stool, liquids and gases from the rectum. Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- ForConti Contix Fecal Incontinence Management System (FIMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2019to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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*
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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 help prevent the involuntary leakage of stool, liquids and gases from the rectum. ForConti Contix FIMS is for an individual with fecal incontinence that has impaired quality of life, is responsive and mentally capable to participate in their own treatment.
This study is designed to evaluate the safety and effectiveness of the ForConti Contix FIMS for its intended use utilizing a baseline period of 2 weeks followed by an on-device period of using the device for 4 weeks and completed with a followup period of 2 weeks.
Read the 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 diapers and pads, medication, biofeedback and anal plugs/balloons and moving on to invasive procedures (i.e. nerve stimulators, restorative surgery, colostomy) where conservative treatment isn't effective.
The main reason for potential pain and discomfort with the current available anal plugs is the plug location within the anus below the dentate line. This part of the anus, which is highly sensitive, may cause discomfort and pain to some users. The advantage of the ForConti Contix Fecal Incontinence Management System (FIMS) is that it is designed to be located in an inner section of the rectum, above the dentate line, and therefore less sensitive and less likely to cause discomfort or pain to the user.
This study is a prospective, non-randomized, single-arm, self-controlled clinical investigation designed to evaluate the safety and effectiveness of the ForConti Contix FIMS. Total duration of the study for each patient will be 8 weeks, including follow-up.
This multi center study will be conducted on 10-20 patients (per site) suffering from accidental bowel leakage due to bowel incontinence and who meet all of the inclusion criteria and none of the exclusion criteria.
The ForConti Contix FIMS includes 2 main parts: the inserted part and the insertion system. The inserted part includes a balloon and a pulling string, and the insertion system includes the applicator and the inflation kit. The balloon is a soft flexible biocompatible, component. It is designed to be located in the rectum by an applicator and to be filled with a pre-determined amount of air to gain its final shape.
- Conditions
- Fecal Incontinence
- Being tested
- ForConti Contix Fecal Incontinence Management System (FIMS)
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ForConti Contix Fecal Incontinence Management System (FIMS)Device
Use the device for up to 12 hours per use for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Assigned Interventions | Experimental | ForConti Contix Fecal Incontinence Management System (FIMS) Receives: Device: ForConti Contix Fecal Incontinence Management System (FIMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of device related serious adverse events
Number of device related serious adverse events
Measured: 6 weeks (4 weeks of use and 2 weeks follow-up)
Rate of subjects who improved by 50% or more in ABL (FI episodes) during the on-device period as compared to the baseline period.
≥40% of subjects reporting ≥50% reduction in FI episodes during the on-device period as compared to the baseline period.
Measured: 8 weeks (2 weeks baseline, 4 weeks of use and 2 weeks follow-up)
Secondary outcomes (2)
Rate of device or procedure related adverse events in the treatment or in the follow-up periods.
Rate of device or procedure related adverse events in the treatment or in the follow-up periods.
Measured: 6 weeks (4 weeks of use and 2 weeks follow-up)
Change in mean scores on subject-reported outcomes related to symptom-specific Fecal Incontinence Quality of Life (FIQoL) Questionnaire.
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 (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale.
Measured: 6 weeks (2 weeks baseline, 4 weeks of use )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study startFeb 2019 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ForConti Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stacy B Menees, MD, Principal investigator, University of Michigan, Department of Medicine, Division of GastroenterologyWilliam D Chey, MD, Principal investigator, University of Michigan, GI Physiology LaboratoryLin Chang, MD, Principal investigator, David Gefen School of Medicine at UCLA, Division of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813251
- Sponsor's protocol ID
- CD-14-002
- Status last verified
- Jan 2019
- First submitted
- 15 Jan 2019
- Last updated
- 23 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Evaluation of the ForConti Contix Fecal Incontinence Management System (FIMS)
- ClinicalTrials.gov ID
- NCT03813251
- Acronym / sponsor ID
- CD-14-002
- Conditions
- Fecal Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ForConti MedicalIndustry (pharma, biotech, devices)
- Study start
- Feb 2019 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 help prevent the involuntary leakage of stool, liquids and gases from the rectum. ForConti Contix FIMS is for an individual with fecal incontinence that has impaired quality of life, is responsive and mentally capable to participate in their own treatment.
This study is designed to evaluate the safety and effectiveness of the ForConti Contix FIMS for its intended use utilizing a baseline period of 2 weeks followed by an on-device period of using the device for 4 weeks and completed with a followup period of 2 weeks.
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 diapers and pads, medication, biofeedback and anal plugs/balloons and moving on to invasive procedures (i.e. nerve stimulators, restorative surgery, colostomy) where conservative treatment isn't effective.
The main reason for potential pain and discomfort with the current available anal plugs is the plug location within the anus below the dentate line. This part of the anus, which is highly sensitive, may cause discomfort and pain to some users. The advantage of the ForConti Contix Fecal Incontinence Management System (FIMS) is that it is designed to be located in an inner section of the rectum, above the dentate line, and therefore less sensitive and less likely to cause discomfort or pain to the user.
This study is a prospective, non-randomized, single-arm, self-controlled clinical investigation designed to evaluate the safety and effectiveness of the ForConti Contix FIMS. Total duration of the study for each patient will be 8 weeks, including follow-up.
This multi center study will be conducted on 10-20 patients (per site) suffering from accidental bowel leakage due to bowel incontinence and who meet all of the inclusion criteria and none of the exclusion criteria.
The ForConti Contix FIMS includes 2 main parts: the inserted part and the insertion system. The inserted part includes a balloon and a pulling string, and the insertion system includes the applicator and the inflation kit. The balloon is a soft flexible biocompatible, component. It is designed to be located in the rectum by an applicator and to be filled with a pre-determined amount of air to gain its final shape.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assigned Interventions | Experimental | Device: ForConti Contix Fecal Incontinence Management System (FIMS)ForConti Contix Fecal Incontinence Management System (FIMS) |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ForConti Contix Fecal Incontinence Management System (FIMS)Use the device for up to 12 hours per use for 4 weeks | Device | Assigned Interventions |
Primary outcome
Number of device related serious adverse events
Time frame: 6 weeks (4 weeks of use and 2 weeks follow-up)
Number of device related serious adverse events
Rate of subjects who improved by 50% or more in ABL (FI episodes) during the on-device period as compared to the baseline period.
Time frame: 8 weeks (2 weeks baseline, 4 weeks of use and 2 weeks follow-up)
≥40% of subjects reporting ≥50% reduction in FI episodes during the on-device period as compared to the baseline period.
2 secondary outcomes
Rate of device or procedure related adverse events in the treatment or in the follow-up periods.
Time frame: 6 weeks (4 weeks of use and 2 weeks follow-up)
Change in mean scores on subject-reported outcomes related to symptom-specific Fecal Incontinence Quality of Life (FIQoL) Questionnaire.
Time frame: 6 weeks (2 weeks baseline, 4 weeks of use )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacy B Menees, MD principal investigator
University of Michigan, Department of Medicine, Division of Gastroenterology
William D Chey, MD principal investigator
University of Michigan, GI Physiology Laboratory
Lin Chang, MD principal investigator
David Gefen School of Medicine at UCLA, Division of Digestive Diseases
Questions about this trial
What is this clinical trial studying?
A study testing ForConti Contix Fecal Incontinence Management System (FIMS) in people with Fecal Incontinence, run by ForConti Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shay Leventhal Gabay, CA/RA Director (+972-4-647-2419, shay.leventhal@forconti-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of device related serious adverse events (time frame: 6 weeks (4 weeks of use and 2 weeks follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.