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NCT06951594

Robotic-Assisted Versus Manual Electrode Array Insertion

Recruiting now NA Last updated 17 July 2025
What this trial tests

NA trial testing Robotic in Cochlear Implantation in 100 participants. Currently enrolling.

Timeline
30 June 2025
Primary endpoint
31 March 2028
31 August 2028

Quick facts

Lead sponsorUniversity of Iowa
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposebasic science
Enrollment100
Start date30 June 2025
Primary completion31 March 2028
Estimated completion31 August 2028
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Iowa

Who can join

Adults 18 to 80, any sex, with Cochlear Implantation or Robotics. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Robotics-assisted electrode insertion overcomes many surgeon-related kinetic limitations such as insertion speed, tremor, drift, and lack of accurate force control. In human cadaveric cochleae, robotics-assisted electrode insertion causes less intracochlear trauma compared to manual insertion. Whether this technical advance results in functional benefits in CI patients remains unknown. To address this critical knowledge gap, the investigators will compare cochlear trauma assessed using CT scans, cochlear and AN function assessed using ECochG and/or the eCAP, and clinical outcomes quantified by postoperative residual acoustic hearing and speech perception scores between participants randomized to either manual or robotics-assisted electrode array insertion.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Robotic

Trials testing the same drug.

Other recruiting trials for Cochlear Implantation

Currently open trials in the same condition.

Other University of Iowa trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06951594.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing