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Medical and Economic Evaluation of a Magnetic Anal Sphincter for Patients With Severe Anal Incontinence

NCT01920607 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2017-06-26

No results posted yet for this study

Summary

The purpose of this study is to compare 2 surgical treatments of severe fecal incontinence (defined as more than a major leak per week). The hypothesis of this "non-inferiority" trial is that magnetic anal sphincter is clinically as effective as SNS, but more cost-effective in managing fecal incontinence

Conditions

  • Fecal Incontinence
  • Anal Incontinence

Interventions

DEVICE

magnetic anal sphincter

DEVICE

sacral nerve stimulation

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-12-31
Completion
2017-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01920607 on ClinicalTrials.gov