Clinical Investigation Study of Safety and Performance of the Sentio System.

April 2, 2024 updated by: Oticon Medical

A Prospective, Multi-center, Single-arm, Clinical Investigation of the Safety and Performance of the Sentio System in Users With Mixed/Conductive Hearing Losses and Single Sided Deafness

Prospective, open label, single-arm, multi-centre investigation, designed to follow clinical practice for Sentio bone conduction devices in 50 subjects, during 10 clinical visits, and 24 months follow-up.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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.

Detailed Description

The investigation is a 24-months multinational, multicentre, prospective, open label, single arm investigation on the Sentio system. The purpose of this investigation is to evaluate safety and performance three months after implantation of the new Sentio system. In addition, safety will be analysed six months after implantation, and long-term safety and performance will be evaluated over a 24-month follow-up period. The endpoints chosen, together with applicable measurements, are commonly used, both in the clinical setting as well as in bone anchored hearing research as shown in the scientific literature covering this area. That is, the primary objectives of this study is to demonstrate that the Sentio system improves hearing and speech recognition on the implanted ear. Secondary objectives includes investigation of hearing improvement, speech intelligibility, patient satisfaction, and quality of life. The study also aims to evaluate the safety profile of the Sentio system in terms of the occurrence of adverse events and serious adverse events related to the device.

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.
51

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
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg Universitätsklinik für Hals,- Nasen und Ohrenheilkunde
      • Hanover, Germany, 30625
        • HNO-Klinik Medizinische Hochschule Hanover
  • Netherlands
      • Groningen, Netherlands, 9700 RB
        • ENT Department, University Medical Center Groningen
      • Nijmegen, Netherlands, 6500 HB
        • ENT department Radboud University Medical Center (Radboud UMC)
  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • ENT - University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital

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:

  1. Signed Informed Consent Form
  2. Adult subjects (18 years or older)

  3. Subjects with 3.1. conductive or mixed hearing losses with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear better than or equal to 45 dB HL.

    3.2. OR subjects who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. SSD). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz) 3.3. OR subjects who are indicated for an air-conduction contralateral routing of signals (ACCROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

  4. Fluent in local language
  5. Subjects who have the ability and are willing to follow investigational procedures/requirements, e.g. to complete quality of life scales.

Exclusion Criteria:

  1. Inability to undergo general or local anesthesia
  2. Prior implantation with percutaneous device or middle ear implant on the side to be implanted
  3. Known medical conditions that contraindicate undergoing surgery as judged by the investigator
  4. Untreated ongoing middle ear infection at the time of surgery
  5. Known insufficient bone quality/quantity/depth or skull size (scull abnormalities) for implantation of a Sentio Ti Implant
  6. Known or suspected contact allergy to silicone or other material used in the Sentio system.
  7. Known condition that could jeopardize wound healing and skin condition e.g. uncontrolled diabetes over time as judged by the investigator.
  8. Known skin or scalp conditions that may preclude attachment or interfere with the usage of the sound processor.
  9. Known retro cochlear pathology and auditory processing disorders that may have an impact on the outcome of the investigation
  10. Any other known condition that the investigator determines could interfere with compliance or investigation assessments.
  11. Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator.
  12. Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy or similar during the investigation period.
  13. For bilateral asymmetric candidates, subject already treated with a bone-anchored hearing solution on the side with the best bone conduction thresholds
  14. Known chronic or non-revisable vestibular or balance disorder
  15. Known abnormally progressive hearing loss
  16. For conductive and mixed losses: evidence that hearing loss is retro-cochlear or of central origin
  17. Participation in another clinical investigation with pharmaceuticals and/or devices which might cause interference with investigation participation.
  18. Use of active implantable or body worn device that for medical reasons cannot be removed or discontinued, such as implantable cardiac pacemakers, defibrillators, or neurostimulators.
  19. Known need for frequent MRI investigations for follow-up of other diseases.
  20. Any subject that according to the Declaration of Helsinki is deemed unsuitable for investigation enrolment.

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: Sentio system
Prospective, open label, single-arm multi-centre investigation following clinical practice for bone conduction devices.
Device: Active transcutaneous bone conduction hearing system
The Sentio system consists of the Sentio 1 sound processor (SP) and Sentio Ti implant with fixation band and screws.
Other Names:
  • Sentio system

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
Demonstrate that the Sentio system improves hearing on the implanted ear.
Time Frame: 3 months post-surgery
Functional gain with Sentio, i.e. the difference between preoperative unaided and aided sound field thresholds on the implanted ear.
3 months post-surgery
Demonstrate that the Sentio system provides patients with improved speech recognition on the implanted ear.
Time Frame: 3 months post-surgery
Difference in speech recognition score in percent between pre-operative unaided condition and aided with Sentio, measured in quiet on the implanted ear.
3 months post-surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Thorough assessment of performance (functional gain, effective gain, speech recognition), satisfaction, usability, comfort and health-related quality of life.
Time Frame: 3-24 months post-surgery
Sound field audiometry, speech testing in quiet and noise and patient reported outcomes on listed topics.
3-24 months post-surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate the safety profile of the Sentio system in terms of the occurrence of adverse events and serious adverse events related to the device.
Time Frame: 3 months post-surgery
Tabulated adverse events and serious adverse events related to the device reported from surgery throughout the investigation reported at 3 months post-surgery
3 months post-surgery

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.
Oticon Medical

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: Myrthe Hol, MD, PhD, ENT Department, University Medical Center Groningen
  • Principal Investigator: Emmanuel Mylanus, MD, PhD, ENT Department, Radboud University Medical Center
  • Principal Investigator: Peter Monksfield, MD, PhD, ENT - University Hospitals Birmingham NHS, Foundation Trust
  • Principal Investigator: James Tysome, MD, PhD, Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital
  • Principal Investigator: Susan Arndt, MD, PhD, Universitätsklinikum Freiburg
  • Study Director: Thomas Lenartz, MD, PhD, HNO-Klinik Medizinische Hochschule Hannover

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.
January 19, 2022

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.
February 19, 2024

Study Completion (Estimated)

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 1, 2025

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).
December 8, 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.
December 8, 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.
December 21, 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.
April 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.
April 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.
April 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.
  • BC101
  • CIV-21-07-037287 (Other Identifier: EUDAMED)
  • CI/2021/0043/GB (Other Identifier: MHRA)

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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