NCT04987684

Brief Summary

Recruit adult patients eligible for cochlear Implant surgery. During routine surgery monitor electrode placement with new 'SCINSEV' technique and complete 'PECAPs' on patient to identify if any of the electrodes have misplaced. Follow up with patient after surgery for post operative appointment with same measurements.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

September 25, 2020

Last Update Submit

August 19, 2021

Conditions

Cochlear Implants

Keywords

cochlear implantelectrophysiologyauditory nerve fibresextra cochlear electrodes

Outcome Measures

Primary Outcomes (1)

  • Validation of extra cochlear electrodes

    Number of extra-cochlear electrodes obtained using our "SCINSEV" analysis correspond to the actual number of extra-cochlear electrodes observed during different stages of insertion.

    12 months

Secondary Outcomes (1)

  • Pre and post op loudness comparison

    12 months

Study Arms (1)

Standard of Care

OTHER
Diagnostic Test: SCINSEV and PECAP

Interventions

SCINSEV and PECAPDIAGNOSTIC_TEST

To measure PECAP and SCINSEVs. To find whether electrodes are outside of the cochlear or within dead regions within the cochlear.

Standard of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant is willing or able to consent to participation in the study
  • Meets normal candidacy requirements for cochlear implantation
  • At least 18 years of age at time of consent being given
  • Patent cochlea as verified by CT or MRI scan
  • No additional complex needs that would prevent study procedures being followed
  • Agreement to participate in the study

You may not qualify if:

  • Using medication in a manner that might affect hearing levels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 OQQ, United Kingdom

Location

Study Officials

  • Daniele Borsetto

    Addenbrookes Hospital, CUH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Researcher

Study Record Dates

First Submitted

September 25, 2020

First Posted

August 3, 2021

Study Start

December 1, 2020

Primary Completion

October 1, 2021

Study Completion

January 1, 2022

Last Updated

August 25, 2021

Record last verified: 2021-08

Locations

GB(1)