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Clinical Trail of Auditory Brainstem Implant System in NF2 Patient

A prospective, single-center, open-label, single-group, target-value clinical trial to evaluate the safety and efficacy of an artificial auditory brainstem implantation system in patients with severe and above deafness caused by neurofibromatosis type 2

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070545
Enrollment
Unknown
Registered
2023-04-15
Start date
2023-04-15
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Neurofibromatosis type 2 causes severe and above deafness

Interventions

Test Group:Auditory Brainstem Implantation

Sponsors

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

Eligibility

Sex/Gender
All
Age
6 Years to 75 Years

Inclusion criteria

Inclusion criteria: ? Patients aged 6-75 years (including 6 and 75 years); ? Severe or above deafness due to neurofibromatosis type 2 (including expected total deafness after surgery) ; ? Audiological assessment and imaging assessment meet the requirements; ? In patients with no contraindications to surgery, the expected postoperative life span was more than 2 years; ? Agreed to participate in the trial and signed an informed consent form;

Exclusion criteria

Exclusion criteria: ? Allergic to the implant material; ? Mental retardation ; ? Mental illness; ? Unable to cooperate with audiological evaluators; ?The abnormal structure of brain tissue affects the evaluators of implant surgery or postoperative effect; ? Follow-up brain stem radiotherapy patients; ? The general condition is poor, unable to accept surgery; ? Uncontrollable seizures; ? Those who were assessed as unsuitable for inclusion by the researcher;

Design outcomes

Secondary

MeasureTime frame
Acoustic field threshold assessment;Electrophysiological assessment;Electrode placement evaluation;

Primary

MeasureTime frame
Total efficacy rate;

Countries

China

Contacts

Public ContactHao Wu

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

lvmt801@163.com+86 13552564506

Outcome results

None listed

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