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NCT01625221 · ClinicalTrials.gov registry record · NA

Feasibility Study of the Magnetic Anal Sphincter (FENIX System)

A NA study of Fecal Incontinence, sponsored by Torax Medical Incorporated.

Completed
Registry status
NA
Development phase
35
Enrollment target
4
Study locations

NCT01625221 is a NA study of Fecal Incontinence that has completed, run by Torax Medical Incorporated. The registered enrollment target is 35 participants, below the 333-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (89% lower). The trial reports 4 study locations across 3 states.

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The verdict

NCT01625221, a NA study of Fecal Incontinence, has completed, sponsored by Torax Medical Incorporated.

COMPLETED
Registry status
NA
Development phase
35 participants
Enrollment target
4
Study locations

Study 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).

Conditions Studied

Fecal Incontinence

Interventions

  • DEVICE Magnetic Anal Sphincter

Study Locations (4)

Other

  • Arhus Universitetshospital - Aarhus
  • University of Medicine - Nantes

Minnesota

  • Colon and Rectal Surgery Associates - Minneapolis

Washington

  • Providence Medical Research Center - Spokane

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2008-12
Est. Completion 2016-03
Phase NA

Sponsor

Torax Medical Incorporated

6 total trials

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What the Registry Record Tells You About NCT01625221

The ClinicalTrials.gov registry entry for NCT01625221 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 333-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (89% lower). The listed sponsor is Torax Medical Incorporated, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Fecal Incontinence appearing as the primary indexed condition, and to 1 intervention - of which Magnetic Anal Sphincter is the first listed.

NCT01625221 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Other, Minnesota, Washington.

Frequently Asked Questions

What is clinical trial NCT01625221 about?

NCT01625221 is a clinical study titled "Feasibility Study of the Magnetic Anal Sphincter (FENIX System)". 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).

What is the current status of trial NCT01625221?

This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2008-12. Estimated completion is 2016-03.

What conditions does trial NCT01625221 study?

This clinical trial studies the following conditions: Fecal Incontinence.

What interventions are being tested in trial NCT01625221?

The interventions under investigation include: Magnetic Anal Sphincter (DEVICE).

Who is sponsoring clinical trial NCT01625221?

This trial is sponsored by Torax Medical Incorporated, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01625221 being conducted?

This trial has 4 study locations across Minnesota, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.