The RW-Precision-Coupler Clinical Investigation

December 2, 2024 updated by: MED-EL Elektromedizinische Geräte GesmbH
The RW-Precision-Coupler Clinical Investigation is prospective, non-randomized, open label, single subjects repeated measures, longitudinal monocentric trial. The primary aim of this pre-market clinical investigation is to evaluate the clinical performance and safety of VSB together with the VSB RWP-Coupler in the treatment of hearing loss. As secondary aims are to evaluate the clinical performance of VSB together with RWP-Coupler by measuring Sound Field audiometry (SF), to evaluate the safety of VSB together with RWP-Coupler by measuring bone conduction (BC) thresholds and collecting and assessing adverse events.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Hannover, Germany
        • Medical School Hannover

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Geographically and physically able to return to the investigational site for scheduled evaluations and follow-up appointments

    • Fluent in the German language
    • Persons of 18 years of age or older
    • Signed and dated informed consent before the start of any study-specific procedure
    • The physician must fully assess the potential risks and benefits for the patient prior to the decision to implant the RW-Precision-Coupler. The physician must exercise medical judgment and consider the patient's complete hospital record (also called medical history)
    • No previous active middle ear implant surgery performed in the implanted ear

    • The following indication for VORP503:

      • For a patient with sensorineural hearing loss, pure-tone air conduction threshold levels at or within the levels listed below:
      • For a patient with conductive or mixed hearing loss, pure tone bone-conduction threshold levels at or within the levels listed below:
      • A patient shall present with an ear anatomy that can facilitate positioning of the FMT in contact with a suitable vibratory structure of the ear.
      • A patient with sensorineural hearing loss shall be a current user of an acoustic hearing aid and have used this aid for at least 4 hours (average) per day for at least 3 months prior to evaluation, or shall not be able to wear or benefit from conventional hearing aids for medical reasons.
      • A patient shall be psychologically and emotionally stable with realistic expectations of the benefits and limitations of the Soundbridge

Exclusion Criteria:

  • Simultaneous participation in another clinical trial (on device or on drug) which would interfere with the results of the study

    • Pregnancy or lactation

    • Contraindication for RWP-Coupler Sizer:

      • if a patient is known to be intolerant of the materials used in the RWP-Coupler.
      • if a patient is known to be intolerant of the materials used in the RWP-Coupler Sizer.
      • in case of a fixed stapes footplate.

    • Contraindication for VORP503:

      • A patient is known to be intolerant of the materials used in the implant (medical grade silicone elastomer, medical grade epoxy and titanium).
      • A patient with retrocochlear, or central auditory disorders.
      • A patient with nonresponsive active ear infection and/or chronic fluid in or about the ear.
      • A patient whose hearing loss has demonstrated an improving and decreasing fluctuation over a two-year period of 15 dB in either direction.
      • A patient with any physical, psychological, or emotional disorder that would interfere with surgery or the ability to perform on test and rehabilitation procedures.
      • A patient with a skin or scalp condition that may preclude attachment of the audio processor with a magnet.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mild to severe hearing loss
Device: RW-Precision-Coupler
Implantation of the RW-Precision-Coupler together with FMT-VORP 503

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Freiburger Monosyllable Test
Time Frame: 6 months post-operative
Investigate the improvement of unaided pre-activation Word Recognition Scores (WRS) to 6 months post-operation aided WRS with RW-Precision-Coupler
6 months post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MED-EL Elektromedizinische Geräte GesmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lenarz Thomas, Prof. h.c. Dr., Medizinische Hochschule Hannover Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020VIB010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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