Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol® Compared to Manual Insertion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 21
- 主要终点
- Speech discrimination score
研究概览
简要总结
The purpose of this study is to evaluate, via a randomised controlled design, the efficacy of the robotic insertion of cochlear implant, versus manual insertion. Robotic insertion will be performed using Robotol.
This is a three years interventional study involving adults with profound bilateral hearing loss.
Eligible subjects will be randomized in two groups : robotic insertion, or manual insertion. Each patient will be followed during 12 months.
详细描述
Cochlear implants are currently the only option for the rehabilitation of bilateral profound hearing loss. Cochlear implant surgery efficacy has been largely demonstrated by numerous studies. But, despite multiple contributors, accuracy and sensitivity of cochlear implant insertion constitute the major and the single factor that surgeons have under control.
This manual surgery is performed in an extremely constrained environment and must be as much as delicate as possible to preserve patient's residual hearing potential. Manual insertion is still largely subject to experience and dexterity of the surgeon. Factors associated with the surgical insertion (such as incomplete or traumatic insertions, translocations, destruction of residual hearing) have a negative impact on final hearing correction performance.
To optimise the hearing results, the insertion must be precise, linear and atraumatic. These conditions may be achieved by robotic insertion.
The RobOtol® is an innovative robotic assistance system dedicated to ear surgery, designed and built in France. This is a compact serial robot with 7 degrees of freedom and high resolution, allowing lower insertion forces and higher insertion depth than the manual approach. Pilot clinical studies have already reported a reduced frequency of translocations via robotic assistance and a reduction in cochlear trauma.
The objective of Robiicca is to evaluate, via a randomised controlled design, the efficacy at 1 year of this robotic technology in cochlear implantation in adults.The hypothesis is that the optimization of the surgical procedure with the RobOtol® will maximize the audiometric results, as well as the residual hearing and the vestibular function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient (age > 18)
- •Eligible for a cochlear implant insertion according to the HAS recommendations
- •Patient having signed an informed consent
排除标准
- •Exclusion Criteria:
- •Profound hearing loss linked to meningitis
- •Bilateral cochlear implants insertion during the same surgery
- •Removal and re-insertion of a cochlear implant (due to a failure for example)
- •Patient under guardianship or curatorship
- •Contraindication to the use of the RobOtol®:
- •Patients wearing electronic devices directly connected to the brain or nervous system.
- •Presence of medical conditions that prohibit general anesthesia. Impossibility of viewing the anatomy adequately. Any situation that, in the doctor's opinion, might involve risk for the patient
- •Anticipated difficulty to comply with the investigation (job transfer, geographical distance, lack of motivation, incapacity to fulfill the questionnaires),
- •Patient previously included in Robiicca study (for the opposite site)
- •Perimodiolar implants (not compatible with the RobOtol®)
结局指标
主要结局
Speech discrimination score
时间窗: 1 year
the speech discrimination score is the percentage of repeated words in silence, with a monosyllabic list, at 60dB, cochlear implant activated.
次要结局
- Speech discrimination score(Baseline, 6 months)
- Complications related to the implant(Day one, 1 month, 3 months, 6 months, 12 months)
- Vestibular function with VHIT(Baseline, 12 months)
- Vestibular function with MVEP(Baseline, 12 months)
- Speech audiometry in noise(6 months, 12 months)
- Rate of electrode translocations(Day one post operative)
- Quality of life of patients with HUI3(Baseline, one month, 3 months, 6 months, 12 months)
- Vestibular function with Caloric test results(Baseline, 12 months)
- Incremental cost-effectiveness ratio (cost per point of speech discrimination score gain) from a collective perspective(12 months)
- Speech Reception Threshold (SRT 50)(6 months, 12 months)
- Rate of incomplete insertion(Day one post operative)
- Residual hearing(Baseline, 6 months, 12 months)
- Pure-tone audiometry(6 months, 12 months)
- Quality of life of patients with EQ-5D(Baseline, one month, 3 months, 6 months, 12 months)