search
Back to results

Feasibility Study of the Magnetic Anal Sphincter (FENIX System)

Primary Purpose

Fecal Incontinence

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Magnetic Anal Sphincter
Sponsored by
Torax Medical Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring FENIX

Eligibility Criteria

19 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 19 years, <85 years, life expectancy >3yrs.
  • Documented history of severe fecal incontinence for at least 6 months
  • Subject diary documents ≥ 2 episodes per week on average over diary period, leakage greater than seepage
  • Subject has failed standard conservative and medical therapy
  • 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:

  • Subject has history of significant obstructed defecation or other significant chronic defecatory motility disorders
  • Subject has current, external full thickness rectal prolapse or vaginal prolapse
  • Subject has an electric or metallic implant within 10cm of the area of device placement
  • Subject has Inflammatory Bowel Disease
  • Subject has Irritable Bowel Syndrome
  • Subject has systemic disease as source of FI (scleroderma, neurologic disorders, Crohn's)
  • Subject has active pelvic infection
  • Subject has chronic diarrhea
  • Subject diagnosed with anal, rectal, or colon cancer within 2 years
  • Subject has had prior anterior resection of the rectum
  • Subject has undergone pelvic radiation therapy
  • Subject has significant scarring of the recto-vaginal septum, a permanent implant in the recto-vaginal septum, or a history of recto-vaginal fistula
  • Subject has had previous anorectal posterior compartment surgery
  • The procedure is an emergency procedure
  • Subject is currently being treated with another investigational drug or investigational device.
  • Subject cannot understand trial requirements or is unable to comply with follow-up schedule.
  • Subject is pregnant or nursing, or plans to become pregnant.
  • Subject has history of complex anal fistula

Sites / Locations

  • Colon and Rectal Surgery Associates
  • Providence Medical Research Center
  • Arhus Universitetshospital
  • University of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Magnetic anal sphincter augmentation

Arm Description

The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.

Outcomes

Primary Outcome Measures

Adverse Events
The safety objective will be met via reporting all adverse events at various time points including implant, 6 weeks, 3 months, 6 months, and 12 months (and then semi-annually until 5 years post-implant at U.S. sites). Serious device- and procedure-related adverse events will be summarized separately. Safety will be characterized by physical examination and pelvic X-ray evaluations.
Reduction in Fecal Incontinence Symptoms
Effectiveness will be characterized as the reduction of FI symptoms by subjective measurements using the FISI, Wexner, and FIQOL scores and a three week diary documenting episodes of incontinence.

Secondary Outcome Measures

Full Information

First Posted
June 19, 2012
Last Updated
December 7, 2017
Sponsor
Torax Medical Incorporated
search

1. Study Identification

Unique Protocol Identification Number
NCT01625221
Brief Title
Feasibility Study of the Magnetic Anal Sphincter (FENIX System)
Official Title
An Observational Clinical Feasibility Study of The Magnetic Anal Sphincter
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Torax Medical Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this feasibility study is to obtain preliminary safety and effectiveness information and develop procedural optimization for the Magnetic Anal Sphincter device (FENIX System) in reinforcement of anal sphincter function to treat severe fecal incontinence (FI).
Detailed Description
Study subjects followed to 12 months post implant outside the U.S. Study subjects followed to 5 years post implant in the U.S.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
Keywords
FENIX

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnetic anal sphincter augmentation
Arm Type
Experimental
Arm Description
The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.
Intervention Type
Device
Intervention Name(s)
Magnetic Anal Sphincter
Intervention Description
The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.
Primary Outcome Measure Information:
Title
Adverse Events
Description
The safety objective will be met via reporting all adverse events at various time points including implant, 6 weeks, 3 months, 6 months, and 12 months (and then semi-annually until 5 years post-implant at U.S. sites). Serious device- and procedure-related adverse events will be summarized separately. Safety will be characterized by physical examination and pelvic X-ray evaluations.
Time Frame
60 months
Title
Reduction in Fecal Incontinence Symptoms
Description
Effectiveness will be characterized as the reduction of FI symptoms by subjective measurements using the FISI, Wexner, and FIQOL scores and a three week diary documenting episodes of incontinence.
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 19 years, <85 years, life expectancy >3yrs. Documented history of severe fecal incontinence for at least 6 months Subject diary documents ≥ 2 episodes per week on average over diary period, leakage greater than seepage Subject has failed standard conservative and medical therapy 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: Subject has history of significant obstructed defecation or other significant chronic defecatory motility disorders Subject has current, external full thickness rectal prolapse or vaginal prolapse Subject has an electric or metallic implant within 10cm of the area of device placement Subject has Inflammatory Bowel Disease Subject has Irritable Bowel Syndrome Subject has systemic disease as source of FI (scleroderma, neurologic disorders, Crohn's) Subject has active pelvic infection Subject has chronic diarrhea Subject diagnosed with anal, rectal, or colon cancer within 2 years Subject has had prior anterior resection of the rectum Subject has undergone pelvic radiation therapy Subject has significant scarring of the recto-vaginal septum, a permanent implant in the recto-vaginal septum, or a history of recto-vaginal fistula Subject has had previous anorectal posterior compartment surgery The procedure is an emergency procedure Subject is currently being treated with another investigational drug or investigational device. Subject cannot understand trial requirements or is unable to comply with follow-up schedule. Subject is pregnant or nursing, or plans to become pregnant. Subject has history of complex anal fistula
Facility Information:
Facility Name
Colon and Rectal Surgery Associates
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Providence Medical Research Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Arhus Universitetshospital
City
Arhus
Country
Denmark
Facility Name
University of Medicine
City
Nantes
Country
France

12. IPD Sharing Statement

Learn more about this trial

Feasibility Study of the Magnetic Anal Sphincter (FENIX System)

We'll reach out to this number within 24 hrs