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Monitoring and surgical technique for minimally invasive cochlear implantation: a prospective multicenter randomized controlled trial

Monitoring and surgical technique for minimally invasive cochlear implantation: a prospective multicenter randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072019
Enrollment
Unknown
Registered
2023-05-31
Start date
2023-05-31
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deafness

Interventions

Robot assisted implantation group:Cochlear implantation
Traditional Technology Group:Cochlear implantation

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) 18 years old and above; 2) Willing to undergo cochlear implantation and meeting the indications, but wearing a hearing aid is ineffective; 3) Low frequency binaural hearing (250500,1kHz) with residual hearing (not less than 80dB).

Exclusion criteria

Exclusion criteria: 1) Those who are unable to cooperate with fine auditory speech assessment; Individuals with intellectual or mental illness 2) Unable to tolerate surgery due to overall condition; 3) Cochlear conditions such as meningitis and cochlear fibrosis are not suitable for electrode implantation.

Design outcomes

Primary

MeasureTime frame
Changes in CM amplitude of intraoperative cochlear electrogram;Audiological indicators;

Secondary

MeasureTime frame
Radiological indicators;Postoperative auditory electrophysiological indicators;

Countries

China

Contacts

Public ContactJia Huan

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School

Huan_jia_orl@163.com+86 136 0179 7481

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026