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NCT01211444 · ClinicalTrials.gov registry record · Phase 2

US Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea

A Phase 2 study of Obstructive Sleep Apnea, sponsored by Apnex Medical.

Completed
Registry status
Phase 2
Development phase
20
Enrollment target
4
Study locations

NCT01211444 is a Phase 2 study of Obstructive Sleep Apnea that has completed, run by Apnex Medical. The registered enrollment target is 20 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (91% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT01211444, a Phase 2 study of Obstructive Sleep Apnea, has completed, sponsored by Apnex Medical.

COMPLETED
Registry status
Phase 2
Development phase
20 participants
Enrollment target
4
Study locations

Study Summary

The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the Hypoglossal Nerve Stimulation (HGNS) System for stimulating the hypoglossal nerve to help maintain airway opening in subjects with Obstructive Sleep Apnea (OSA).

Conditions Studied

Interventions

  • DEVICE HGNS Treatment

Study Locations (4)

California

  • University of California San Francisco - San Francisco

Indiana

  • Saint Vincent Hospital - Indianapolis

Minnesota

  • University of Minnesota - Minneapolis

New York

  • Clinilabs, Inc. - New York

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2010-07
Est. Completion 2013-08
Phase Phase 2

Sponsor

Apnex Medical

2 total trials

What the Registry Record Tells You About NCT01211444

The ClinicalTrials.gov registry entry for NCT01211444 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (91% lower). The listed sponsor is Apnex Medical, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 1 intervention - of which HGNS Treatment is the first listed.

NCT01211444 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Indiana, Minnesota.

Frequently Asked Questions

What is clinical trial NCT01211444 about?

NCT01211444 is a clinical study titled "US Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea". The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the Hypoglossal Nerve Stimulation (HGNS) System for stimulating the hypoglossal nerve to help maintain airway opening in subjects with Obstructive Sleep Apnea (OSA).

What is the current status of trial NCT01211444?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2010-07. Estimated completion is 2013-08.

What conditions does trial NCT01211444 study?

This clinical trial studies the following conditions: Obstructive Sleep Apnea.

What interventions are being tested in trial NCT01211444?

The interventions under investigation include: HGNS Treatment (DEVICE).

Who is sponsoring clinical trial NCT01211444?

This trial is sponsored by Apnex Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01211444 being conducted?

This trial has 4 study locations across California, Indiana, Minnesota, New York. 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.