NCT03294681

Brief Summary

The aim of this descriptive study is to collect and describe the characteristics of objective measures to explore the specificity of algorithms.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
3 countries

6 active sites

Status
completed

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 15, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

October 3, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 29, 2020

Completed
Last Updated

June 29, 2020

Status Verified

June 1, 2020

Enrollment Period

1.7 years

First QC Date

September 15, 2017

Results QC Date

May 20, 2020

Last Update Submit

June 26, 2020

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • Specificity (%) of Transimpedance Measurement to Identify Electrode Fold-over

    Measured with Custom SoundTM EP 5. It took one minute to measure all electrodes in surgery. Intraoperative transimpedance measures from 148 ears without fold-overs (as evidenced by radiographic imaging) were analysed to assess the specificity of the algorithm.

    at surgery, within one minute

Study Arms (1)

Cochlear Implant Recipients

Device: Objective measures with CSEP

Interventions

Objective measures with CSEPDEVICE

Objective measures to be conducted with Custom SoundTM EP 5 software and the CP900 series sound processor in CI532 and CI512 Cochlear Implant recipients

Cochlear Implant Recipients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Routine patients undergoing a standard cochlear implantation.

You may qualify if:

  • Candidate for cochlear implantation with the CI532 or CI512 devices
  • years of age or older at the time of enrolment
  • Normal cochlea anatomy, established via pre-operative Computer Tomography
  • Willingness to participate in and to comply with all requirements of the protocol

You may not qualify if:

  • Prior cochlear implantation in the ear to be implanted
  • Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
  • Abnormal cochlear anatomy on pre-operative Computer Tomography or Magnetic Resonance Imaging
  • Additional handicaps that would prevent participation in evaluations
  • Pregnant and breast feeding women, prisoners, or anyone in custody
  • Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

HEARing CRC

Carlton, Australia

Location

Hals-Nasen-Ohren-Klinik Universitätsklinikum Erlangen

Erlangen, Germany

Location

Klinik für Hals-, Nasen-, Ohrenheilkunde Universitätsklinikum Frankfurt Goethe-Universität

Frankfurt am Main, Germany

Location

Universitätsklinikum Schleswig- Holstein - Campus Kiel Klinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie

Kiel, Germany

Location

Complejo Hospitalario Universitario Insular Materno Infantil

Las Palmas de Gran Canaria, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Spain

Location

Related Publications (1)

  • Hoppe U, Brademann G, Stover T, Ramos de Miguel A, Cowan R, Manrique M, Falcon-Gonzalez JC, Hey M, Baumann U, Huarte A, Liebscher T, Bennett C, English R, Neben N, Ramos Macias A. Evaluation of a Transimpedance Matrix Algorithm to Detect Anomalous Cochlear Implant Electrode Position. Audiol Neurootol. 2022;27(5):347-355. doi: 10.1159/000523784. Epub 2022 Mar 18.

    PMID: 35306487DERIVED

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Nicole Neben
Organization
Cochlear
nneben@cochlear.com
+4951154277220

Study Officials

  • Bart Volckaerts, PhD

    Cochlear

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2017

First Posted

September 27, 2017

Study Start

October 3, 2017

Primary Completion

May 29, 2019

Study Completion

May 29, 2019

Last Updated

June 29, 2020

Results First Posted

June 29, 2020

Record last verified: 2020-06

Locations

AU(1)DE(3)ES(2)