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COMPLETED NA

Feasibility Study of the Magnetic Anal Sphincter (FENIX System)

NCT01625221 · View on ClinicalTrials.gov ↗

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

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

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01625221

The ClinicalTrials.gov registry entry for NCT01625221 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Torax Medical Incorporated, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01625221 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Other, Minnesota, Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01625221?

The interventions under investigation include: Magnetic Anal Sphincter (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01625221?

This trial is sponsored by Torax Medical Incorporated, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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