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Safety and Effectiveness Evaluation of the ForConti Contix Fecal Incontinence Management System (FIMS)

Primary Purpose

Fecal Incontinence

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

ForConti Contix Fecal Incontinence Management System (FIMS)

About this trial

This is an interventional treatment trial for Fecal Incontinence

Eligibility Criteria

22 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Assigned Interventions

Arm Description

ForConti Contix Fecal Incontinence Management System (FIMS)

Outcomes

Primary Outcome Measures

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.

≥40% of subjects reporting ≥50% reduction in FI episodes during the on-device period as compared to the baseline period.

Secondary Outcome Measures

Rate of device or procedure related adverse events in the treatment or in the follow-up periods.

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.

Full Information

NCT ID

NCT03813251

First Posted

January 15, 2019

Last Updated

January 20, 2019

Sponsor

ForConti Medical

1. Study Identification

Unique Protocol Identification Number

NCT03813251

Brief Title

Safety and Effectiveness Evaluation of the ForConti Contix Fecal Incontinence Management System (FIMS)

Official Title

Safety and Effectiveness Evaluation of the ForConti Contix Fecal Incontinence Management System (FIMS)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 2019 (Anticipated)

Primary Completion Date

August 2019 (Anticipated)

Study Completion Date

August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ForConti Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fecal Incontinence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Assigned Interventions

Arm Type

Experimental

Arm Description

ForConti Contix Fecal Incontinence Management System (FIMS)

Intervention Type

Device

Intervention Name(s)

ForConti Contix Fecal Incontinence Management System (FIMS)

Intervention Description

Use the device for up to 12 hours per use for 4 weeks

Primary Outcome Measure Information:

Title

Number of device related serious adverse events

Description

Number of device related serious adverse events

Time Frame

6 weeks (4 weeks of use and 2 weeks follow-up)

Title

Rate of subjects who improved by 50% or more in ABL (FI episodes) during the on-device period as compared to the baseline period.

Description

≥40% of subjects reporting ≥50% reduction in 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)

Secondary Outcome Measure Information:

Title

Rate of device or procedure related adverse events in the treatment or in the follow-up periods.

Description

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)

Title

Change in mean scores on subject-reported outcomes related to symptom-specific Fecal Incontinence Quality of Life (FIQoL) Questionnaire.

Description

Time Frame

6 weeks (2 weeks baseline, 4 weeks of use )

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shay Leventhal Gabay, CA/RA Director

Phone

+972-4-647-2419

shay.leventhal@forconti-medical.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stacy B Menees, MD

Organizational Affiliation

University of Michigan, Department of Medicine, Division of Gastroenterology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

William D Chey, MD

Organizational Affiliation

University of Michigan, GI Physiology Laboratory

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lin Chang, MD

Organizational Affiliation

David Gefen School of Medicine at UCLA, Division of Digestive Diseases

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Safety and Effectiveness Evaluation of the ForConti Contix Fecal Incontinence Management System (FIMS)

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