Exploring the Use of ECochG Testing During Electrode Insertion in Cochlear Implant Surgery

NCT03807830 | Completed

• 1 other identifier: 18/EE/0304
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Investigation of a new ECoChG system (Electrocochleography) during the surgical insertion of cochlear implants, for patients with Advanced Bionics devices. The sound recordings created may be useful in aiding the surgeon to better implant the patient by letting him or her know if they are damaging the ear during implantation in real time Patients will be followed up for 1 year post surgery within our trial, and have a further 3 ECochGs performed in the clinic setting, (6 weeks, 6 months, 1 year) through their implants.

Conditions

Cochlear Implants; Hearing Preservation

Outcome Measures

Primary Outcomes (1)

• Measure cochlear micro phonic amplitude

  To measure objectively the cochlear micro phonic amplitude either intra or post operatively within initial 12 months of cochlear implant use

  12 months

Study Arms (1)

One arm feasbility study

OTHER

Procedure: Electrocochlography

Interventions

Electrocochlography PROCEDURE

Intra-operative ECochG recording via the implant, post operative ECochG measurements. Impedances measured over time.

One arm feasbility study

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between ages of 12 months to 6 years old, and Adults over 18 years old
• Meets normal candidacy requirements for cochlear implantation
• Advanced Bionics (AB) implant has been selected for patient at MDT
• Patient has capacity to consent
• Patent cochlea as verified by CT or MRI scan
• No cochlear abnormality that might prevent insertion of the electrode array
• Measurable residual hearing in the ear to be implanted
• No additional handicap that would prevent study procedures being followed
• Agreement to participate in the study

You may not qualify if:

• Complex cases where minimal duration of surgery is required. Although ECochG adds less than 10 minutes to the surgery time.
• Patients lacking the capacity to consent

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• University of Cambridge: collaborator

Study Sites (1)

Addenbrookes Hospital

Cambridge, United Kingdom

Location

Study Officials

• Manohar L Bance, MD

  The Emmeline Centre for Cochlear Implants

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hearing implant nurse. Prof M Bance Chief Investigator.

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 17, 2019
• Study Start: January 11, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: November 26, 2019

Record last verified: 2019-11

Locations

GB (1)