Hearing and Structure Preservation Via ECochG (PRESERVE)

February 12, 2024 updated by: Advanced Bionics AG

Preservation of Hearing and Structure Using an Electrocochleography Based Corrective Action Guide

The goal of the study is to determine the benefit of using an ECochG-based corrective action guide during cochlear implant surgery compared to the traditional surgical approach without ECochG surveillance and guidance.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Cochlear implantation is a highly effective method of rehabilitating hearing in individuals with severe to profound hearing loss. One current hurdle to optimising hearing outcomes following cochlear implantation is the unavoidable trauma caused to the inner ear during implant surgery. This damage can mean residual hearing that would remain valuable following implantation is lost. Various approaches have been trialed to preserve hearing during implantation surgery, modifying implantation technique and administering steroids. Electrocochleography (ECochG) is a monitoring technique that can be used during electrode insertion to record inner ear structural integrity and function.

The PRESERVE trial is an international, multi-centre, randomised controlled trial. The trial will randomly allocate adult cochlear implant recipients to undergo implantation surgery either with ECochG-guidance, or via the standard approach without guidance. Participants will be blinded, meaning they will not know which group they will be allocated to. Where ECochG is used, evidence of damage during insertion detected with the monitoring will trigger the surgeon to follow a corrective pathway. All other aspects of surgery and post operative care will follow standard clinical pathways for both groups.

Participants will have their natural hearing measured preoperatively, and 3- and 6-months following implant activation. The change in natural hearing thresholds at different frequencies, and the degree of hearing preservation will then be calculated and compared between the standard surgery and ECochG-guided group. Using their cochlear implant, understanding of speech will also be measured and compared between groups. In addition, participants will undergo a second CT scan following implantation surgery, and this will be compared to the routine pre-operative imaging to assess both the location of the implant electrode, and structural preservation of the cochlear. Throughout the study participants will remain under the care of their routine medical team.

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • 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 Backup

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
        • Contact:
        • Principal Investigator:
          • Ingeborg Dhooge, Dr
        • Principal Investigator:
          • Freya Swinnen, Dr
  • France
      • Tours, France, 37000
        • Le Centre Hospitalier Régional Universitaire de Tours
        • Contact:
        • Principal Investigator:
          • David Bakhos, Prof
        • Principal Investigator:
          • Mathieu Robier, Mr
  • Germany
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg Klinik
        • Contact:
        • Principal Investigator:
          • Antje Aschendorff, Prof
        • Principal Investigator:
          • Thomas Wesarg, Dr
  • Italy
    • TO
      • Torino, TO, Italy, 10141
        • Ospedale Martini
        • Principal Investigator:
          • Diego Di Lisi, Dr
        • Principal Investigator:
          • Patrizia Consolino, Dr
  • Poland
    • Nadarzyn
      • Warsaw, Nadarzyn, Poland, 05-830
        • World Hearing Center
        • Contact:
        • Principal Investigator:
          • Piotr Skarżyński, Prof
        • Principal Investigator:
          • Adam Walkowiak, Dr
  • United Kingdom
    • England
      • Cambridge, England, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Matthew E Smith, Dr
        • Principal Investigator:
          • Patrick Axon, Dr

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18 years of age or older
  • Within cochlear implant inclusion criteria by local regulations/guidelines at the time of implantation
  • Severe to profound hearing loss (average air conduction unaided hearing threshold of ≥ 70 dB HL for 500, 1000, 2000 and 4000 Hz) in the ear to be implanted
  • Air conduction unaided hearing threshold ≤ 70 dB HL at 500 Hz in the ear to be implanted
  • Less than 15 years of severe to profound deafness on the implant ear prior to surgery
  • Post-lingually acquired hearing loss in the ear to be implanted
  • Normal cochlear anatomy as confirmed by pre-operative imaging in the ear to be implanted
  • Listed for an Advanced Bionics HiRes Ultra (3D) HiFocus SlimJ electrode array
  • Listed for cochlear implant surgery under general anaesthesia
  • Fluent in local language
  • Given informed consent to participate in the study

Exclusion Criteria:

  • Abnormal cochlear anatomy (including ossification) as identified by pre-operative radiological evaluation in the ear to be implanted
  • Any pre-existing cochlear or middle ear pathology, such as otosclerosis, cholesteatoma, or previous middle ear surgery in the ear to be implanted
  • Any medical conditions that would increase the risk of local complications during cochlear implantation, such as autoimmune diseases or active local infections
  • Diagnosis of auditory spectrum neuropathy disorder
  • Deafness due to lesions of the acoustic nerve or central auditory pathway
  • Deafened by meningitis
  • Single sided deafness (average for 500, 1000, 2000 and 4000 Hz in the better ear ≤ 30 dB HL)
  • Asymmetric hearing loss (average for 500, 1000, 2000 and 4000 Hz in the better ear > 30 dB HL and ≤ 55 dB HL)
  • History of previous cochlear implantation/re-implantation on either ear
  • Any contraindications to computed tomography (CT) scans
  • Concurrent participation in other cochlear implant related studies

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
ECochG monitored CI surgery incl. corrective action guide
Procedure: ECochG monitored CI surgery incl. corrective action guide
Interventional surgery with surgeon having access to intra-operative ECochG monitoring feedback to deploy ECochG based corrective action guide
Active Comparator: Control
Routine CI surgery without ECochG monitoring
Procedure: Routine CI surgery without ECochG monitoring
Routine CI surgery with access to ECochG monitoring by surgeon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing Preservation
Time Frame: From pre-operative to 6 months post-operative
Difference in dB (absolute) and % (relative) in low-frequency hearing preservation measured via air conduction pure tone audiometry
From pre-operative to 6 months post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Structure Preservation
Time Frame: 1 month post-operative
Difference in mm of structure preservation (distance from electrode contact to basilar membrane) via radiological assessment of the position of the electrode array
1 month post-operative
Speech perception
Time Frame: From pre-operative to 6 months post-operative
Difference in speech perception scores in both quiet (%) and noise (dB SNR) using the International Matrix Test
From pre-operative to 6 months post-operative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgeons' feedback
Time Frame: Through study completion, an average of 2.5 years
Qualitative feedback on surgical experience measured via a questionnaire
Through study completion, an average of 2.5 years

Collaborators and Investigators

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

Sponsor

Advanced Bionics AG

Investigators

  • Principal Investigator: Matt E Smith, Dr, Cambridge University Hospitals NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Estimated)

February 29, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABIntl-23-25

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

product manufactured in and exported from the U.S.

Yes

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.

Clinical Trials on Hearing Loss, Sensorineural

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe