Fecal IncontinenceNCT02865291
Safety and Effectiveness Evaluation of the ForConti Fecal Management System - Pilot Study
A study testing ForConti device in people with Fecal Incontinence, run by ForConti Medical.
Trial summary
The ForConti Fecal Incontinence Management System (FIMS) is indicated for the management of accidental bowel leakage due to bowel incontinence. The ForConti FIMS is designed for self-insertion 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 18 to 85 years
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- ForConti device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Dec 2018
- 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 18 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 and data collection. Patient has the ability to self-manage insertion and removal of the device.
- Patient age is between 18 and 85 years old
- History of fecal incontinence for at least 6 months
- A minimum of four incontinence episodes during the 2-week baseline period
- Patient colon surveillance must be in compliance with the Ministry of Health National Program American Cancer Society colon for the Early Detection of Colorectal Cancer screening guidelines.
- Patient comprehends study meaning \& is capable of carrying out study duties.
Who cannot join
- Spinal cord injury or other major neurological diagnosis
- Known life threatening disease such as cancer, immune deficiency state
- Significant cardiac arrhythmia
- Pregnant or Breastfeeding
- Inflammatory bowel disease
- Anti-coagulants and anti-platelets treatment, except Aspirin (low dose: 75-100 mg/day)
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- Anorectal diseases: perianal abscess, active fistula, fissure, hemorrhoids grade 3 or 4, Pruritus ani or rectal bleeding
- Chronic pelvic pain
- Rectal surgery in past 6 months
About this study
The ForConti Fecal Incontinence Management System (FIMS) is indicated for the management of accidental bowel leakage due to bowel incontinence. The ForConti FIMS is designed for self-insertion to seal and help prevent the involuntary leakage of stool, liquids and gases from the rectum.
The purpose of the study is to demonstrate that the ForConti FIMS is safe and that it improves management of fecal incontinence and improves quality of life.
Patients will record bowel events in a daily diary over a 6 week period, which includes 2 weeks without using the device followed by 4 weeks using the device. Quality of Life questionnaire will be completed before and after use of the device. Stool leakage data collected when the device is not being used will be compared with data collected during use of the device to determine effectiveness.
Read the detailed description
There are several devices for treating bowel incontinence. However, available devices have limited success. Sphincter bulking agents and electrical stimulation did not demonstrate effectiveness in clinical studies. Anal plugs did show some effectiveness but are associated with discomfort and pain. Hence, patients prefer not to use them.
The main reason for 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 it causes discomfort and pain to the user. The advantage of the ForConti device is that it is designed to be located at a more inner section of the anal canal, above the dentate line, which is much less sensitive thus does not cause discomfort to the user.
This is a prospective, feasibility, non-randomized, single-arm, self-controlled study for preliminary safety and effectiveness. Total duration of the study for each patient will be 8 weeks, including follow-up.
The study will be conducted on up to 20 patients suffering from accidental bowel leakage due to bowel incontinence and who meet all of the inclusion criteria and none of the exclusion criteria. Following first 5 cases, interim preliminary safety analysis was conducted and a report submitted to Ministry of Health for approval to continue the study. Approval was granted.
Primary Safety: No device related serious adverse events. Secondary Safety: Minimal rate of device or procedure related adverse events (intra and post-operative complications) in the treatment or in the follow-up periods.
Effectiveness:
Demonstrate the effectiveness of the system by:
A Relative Percentage Change in Episodes of Accidental Bowel Leakage (ABL, FI episodes) Determined by Comparing Active Weeks to Control Weeks Results as measured by Daily Diary Recordings.
Active Weeks are the 3rd and 4th week of study treatment period and the Control Weeks are the baseline 2 weeks assessment period before starting treatment.
Other Measurements:
Usability: Evaluation of SUS Scores Quality of Life: Recording and Evaluation of a validated symptom-specific Fecal Incontinence Quality of Life (FIQoL) Questionnaire Number of incontinence days while using the device during the two-week assessment period, as compared to the baseline two-week assessment period.
The ForConti 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, plunger and the inflator. The balloon is a flexible biocompatible, silicone-based, oval-shaped, furled 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. The silicone surface is equipped with silicone gags which provide better sustainability in the rectum.
- Conditions
- Fecal Incontinence
- Being tested
- ForConti device
- 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 deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| ForConti device | Experimental | Use the device up to 12 hours/day for 4 weeks Receives: Device: ForConti device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
4 weeks of use and 2 weeks follow-up
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ForConti Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Beer-Gabel, MD, Sheba Medical CenterJosef Lysi, MD, Shaheed Ziaur Rahman Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865291
- Sponsor's protocol ID
- CD-14-001
- Status last verified
- Jun 2018
- First submitted
- 9 Aug 2016
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Evaluation of the ForConti Fecal Management System - Pilot Study
- ClinicalTrials.gov ID
- NCT02865291
- Acronym / sponsor ID
- CD-14-001
- Conditions
- Fecal Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ForConti MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 12 Aug 2016 (estimated)
- 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 Fecal Incontinence Management System (FIMS) is indicated for the management of accidental bowel leakage due to bowel incontinence. The ForConti FIMS is designed for self-insertion to seal and help prevent the involuntary leakage of stool, liquids and gases from the rectum.
The purpose of the study is to demonstrate that the ForConti FIMS is safe and that it improves management of fecal incontinence and improves quality of life.
Patients will record bowel events in a daily diary over a 6 week period, which includes 2 weeks without using the device followed by 4 weeks using the device. Quality of Life questionnaire will be completed before and after use of the device. Stool leakage data collected when the device is not being used will be compared with data collected during use of the device to determine effectiveness.
Detailed description
There are several devices for treating bowel incontinence. However, available devices have limited success. Sphincter bulking agents and electrical stimulation did not demonstrate effectiveness in clinical studies. Anal plugs did show some effectiveness but are associated with discomfort and pain. Hence, patients prefer not to use them.
The main reason for 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 it causes discomfort and pain to the user. The advantage of the ForConti device is that it is designed to be located at a more inner section of the anal canal, above the dentate line, which is much less sensitive thus does not cause discomfort to the user.
This is a prospective, feasibility, non-randomized, single-arm, self-controlled study for preliminary safety and effectiveness. Total duration of the study for each patient will be 8 weeks, including follow-up.
The study will be conducted on up to 20 patients suffering from accidental bowel leakage due to bowel incontinence and who meet all of the inclusion criteria and none of the exclusion criteria. Following first 5 cases, interim preliminary safety analysis was conducted and a report submitted to Ministry of Health for approval to continue the study. Approval was granted.
Primary Safety: No device related serious adverse events. Secondary Safety: Minimal rate of device or procedure related adverse events (intra and post-operative complications) in the treatment or in the follow-up periods.
Effectiveness:
Demonstrate the effectiveness of the system by:
A Relative Percentage Change in Episodes of Accidental Bowel Leakage (ABL, FI episodes) Determined by Comparing Active Weeks to Control Weeks Results as measured by Daily Diary Recordings.
Active Weeks are the 3rd and 4th week of study treatment period and the Control Weeks are the baseline 2 weeks assessment period before starting treatment.
Other Measurements:
Usability: Evaluation of SUS Scores Quality of Life: Recording and Evaluation of a validated symptom-specific Fecal Incontinence Quality of Life (FIQoL) Questionnaire Number of incontinence days while using the device during the two-week assessment period, as compared to the baseline two-week assessment period.
The ForConti 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, plunger and the inflator. The balloon is a flexible biocompatible, silicone-based, oval-shaped, furled 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. The silicone surface is equipped with silicone gags which provide better sustainability in the rectum.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ForConti device | Experimental | Device: ForConti deviceUse the device up to 12 hours/day for 4 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient has signed the informed consent form and is willing to participate in the clinical study and data collection. Patient has the ability to self-manage insertion and removal of the device.
- Patient age is between 18 and 85 years old
- History of fecal incontinence for at least 6 months
- A minimum of four incontinence episodes during the 2-week baseline period
- Patient colon surveillance must be in compliance with the Ministry of Health National Program American Cancer Society colon for the Early Detection of Colorectal Cancer screening guidelines.
Key exclusion criteria (9 listed)
- Spinal cord injury or other major neurological diagnosis
- Known life threatening disease such as cancer, immune deficiency state
- Significant cardiac arrhythmia
- Pregnant or Breastfeeding
- Inflammatory bowel disease
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 device | Device | ForConti device |
Primary outcome
Adverse events
Time frame: 6 weeks
4 weeks of use and 2 weeks follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- 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.
Mark Beer-Gabel, MD
Sheba Medical Center
Josef Lysi, MD
Shaheed Ziaur Rahman Medical College
Questions about this trial
What is this clinical trial studying?
A study testing ForConti device 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 6 inclusion and 9 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 25 Jun 2018. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 6 weeks). 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 25 Jun 2018.