Robot-assisted cochlear implantation for full scalar tympani insertion of electrode array and the audiological benefits: a prospective, intra-individual, randomized controlled trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000036534

Enrollment

Unknown

Registered

2020-08-24

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-09-14

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

Conditions

Sensorineural hearing loss

Interventions

Robot-assisted group1 (modiolar-hugging EA):Robot-assisted electrode array insertion

Robot-assisted group2 (middle-scala EA):Robot-assisted electrode array insertion

Robot-assisted group3 (lateral wall EA):Robot-assisted electrode array insertion

Manual group1 (modiolar-hugging EA):Manual insertion of electrode array

Manual group2 (middle-scala EA):Manual insertion of electrode array

Manual group3 (lateral wall EA):Manual insertion of electrode array

Eligibility

Sex/Gender

All

Age

0.5 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Patients with bilateral severe to profound sensorineural hearing loss whose age are >= 6 months; deafness duration is less than 15 years; patients cannot be benefited from hearing aids; candidate for cochlear implantation 2) No important abnormalities of inner ear was observed by CT/MRI; 3) Patients have no contraindications to general anesthesia; 4) Bilateral cochlear implantation with same model of implants.

Exclusion criteria

Exclusion criteria: 1) Previous systemic diseases (heart, nervous system, kidney, liver or coagulation system); 2) Patient currently uses other systemic diseases such as anticoagulant drugs, active or active infections; 3) Patients who do not follow this protocol; 4) Patients who refuse to participate for any reason; 5) Patients who are expected to have poor auditory outcome with CI (anatomical factors, family factors, etc); 6) CT/MRI reconstruction revealed important abnormality of inner ear

Design outcomes

Primary

Measure	Time frame
Number of scalar deviation electrodes;	—

Secondary

Measure	Time frame
Auditory function (PTA);Auditory function (SRS);Auditory electrophysiological indicators (NRT);Auditory electrophysiological indicators (electrode resistance);Auditory electrophysiological indicators (T-level);Auditory electrophysiological indicators (C-Level);Auditory electrophysiological indicators (Stapedius reflex threshold);	—

Countries

China

Contacts

Public ContactHuan jia

Department of Otolaryngology, Head & Neck Surgery, Shanghai Ninth People’s Hospital, affiliated to Shanghai Jiaotong University School of Medicine

huan_jia_orl@163.com+86 13601797481

Outcome results

None listed

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