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NCT01671176 · ClinicalTrials.gov registry record · NA

Wide Diameter Bone Anchored Implant Study

A NA study of Conductive Hearing Loss and Conductive and Sensori-neural Hearing Loss in the Same Ear, sponsored by Oticon Medical.

Completed
Registry status
NA
Development phase
30
Enrollment target
2
Study locations

NCT01671176 is a NA study of Conductive Hearing Loss and Conductive and Sensori-neural Hearing Loss in the Same Ear that has completed, run by Oticon Medical. The registered enrollment target is 30 participants. The trial reports 2 study locations across 2 states.

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The verdict

NCT01671176, a NA study of Conductive Hearing Loss and Conductive and Sensori-neural Hearing Loss in the Same Ear, has completed, sponsored by Oticon Medical.

COMPLETED
Registry status
NA
Development phase
30 participants
Enrollment target
2
Study locations

Study Summary

To assess implant stability, implant loss, adverse skin reactions, and Quality of Life Benefit following implantation of the Ponto 4.5mm Wide Diameter implant. Secondary: to determine the feasibility of fitting the sound processor 3 weeks after surgical implantation, and to investigate if the type of skin reactions following implantation could be related to the demographic data of subjects and the type of surgical technique used

Interventions

  • DEVICE Wide diameter bone anchored implant

Study Locations (2)

Florida

  • Silverstein Institute - Sarasota

Michigan

  • Michigan Ear Institute - Farmington Hills

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2012-05
Est. Completion 2014-11
Phase NA

Sponsor

Oticon Medical

7 total trials

What the Registry Record Tells You About NCT01671176

The ClinicalTrials.gov registry entry for NCT01671176 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oticon Medical, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Conductive Hearing Loss appearing as the primary indexed condition, and to 1 intervention - of which Wide diameter bone anchored implant is the first listed.

NCT01671176 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, Michigan.

Frequently Asked Questions

What is clinical trial NCT01671176 about?

NCT01671176 is a clinical study titled "Wide Diameter Bone Anchored Implant Study". To assess implant stability, implant loss, adverse skin reactions, and Quality of Life Benefit following implantation of the Ponto 4.5mm Wide Diameter implant. Secondary: to determine the feasibility of fitting the sound processor 3 weeks after surgical implantation, and to investigate if the type o...

What is the current status of trial NCT01671176?

This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2012-05. Estimated completion is 2014-11.

What conditions does trial NCT01671176 study?

This clinical trial studies the following conditions: Conductive Hearing Loss, Conductive and Sensori-neural Hearing Loss in the Same Ear, Unilateral, Profound Sensori-neural Hearing Loss.

What interventions are being tested in trial NCT01671176?

The interventions under investigation include: Wide diameter bone anchored implant (DEVICE).

Who is sponsoring clinical trial NCT01671176?

This trial is sponsored by Oticon Medical, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01671176 being conducted?

This trial has 2 study locations across Florida, Michigan. 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

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