DRKS00032341招募中3 期
nilateral implantation of the SPIRION Laryngeal Pacemaker in patients without previous permanent glottal enlargement
MED-EL Elektromedizinische Geräte GmbH0 个研究点目标入组 20 人开始时间: 2023年7月24日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •General information
- •The following patient categories can be recruited into this clinical investigation if they comply with all the selection criteria:
- •Patients recruited in the previous FIH clinical investigation 2011CIP001
- •Patients with an open tracheostoma at the time of enrolment
- •Inclusion Criteria:
- •Between 18 and 75 years old at the time of enrolment (i.e., ICF signed)
- •Diagnosed with BVFP for a minimum of 6 months
- •With sufficient autonomous respiratory capacity to maintain their vital functions independently of the SPIRION Laryngeal Pacemaker. Before a permanent closure of the tracheostomy is carried out during this clinical investigation, the Principal Investigator shall confirm that at least at rest, the failure of the SPIRION Laryngeal Pacemaker would not put the patient in a life-threatening condition because of insufficient respiratory patency
- •At least one PCA responds to electrical stimulation (clear abduction of the respective VF in response to electrical stimulation) within an ECE50 test, or shows reinnervation in an LEMG assessment
- •Fluent in German.
排除标准
- •Lack of compliance with any inclusion criteria
- •Pregnant or breast-feeding women
- •Patients suffering from an ongoing or chronic laryngeal inflammation at the time of enrolment
- •Vocal fold immobility caused by arytenoid joint dysfunctions (e.g., arthritis, scarring, etc.), malignancies, CNS pathologies, and/or systemic diseases
- •Patients who underwent previous permanent surgical glottal enlargement
- •Patients who underwent any other laryngeal surgeries (e.g., laryngeal framework surgery) that would compromise the correct SPIRION Electrode placement and/or the intended functionality of the SPIRION Laryngeal Pacemaker
- •The adductor laryngeal muscles on either or both sides underwent a botulinum toxin injection that is still effective at the time of surgery (i.e., the respective VF position is either in intermediate or lateral position)
- •Patients who underwent thoracic surgeries that would compromise at least one of the following procedures:
- •- Correct placement of the SPIRION Electrode or SPIRION Implant
- •- Connection of the SPIRION Implant with the SPIRION Electrode
- •- Connection of the SPIRION Implant with the external SPIRION Processor
- •Patients wearing an active implantable medical device at the time of enrolment
- •Patients with a clinical history that would suggest a high probability that they would need an MRI
- •Patients diagnosed with a malignant disease in the head and neck region
- •Patients diagnosed with chronic airway infections or obstructions, or severe respiratory diseases (e.g., COPD grade II or higher)
- •Patients who underwent external beam radiation therapy in the surgical area
- •Patients diagnosed with a serious coagulation disorder requiring an uninterruptable use of anticoagulants
- •Patients with known allergies to the SPIRION Laryngeal Pacemaker material in direct contact with the human body
- •Patients suffering from severe depression or any other psychological or psychiatric disease
- •Any anatomic, physiological, or medical conditions that may increase the risks linked to the SPIRION Laryngeal Pacemaker implantation and/or reduce its benefit for the patient
- •Parallel participation in a device/drug clinical investigation in the period of data collection, which could confound the results of this clinical investigation
- •Anything that, in the opinion of the Principal Investigator, would place the patient at increased risk or preclude the patient's full compliance with the general requirements of this clinical investigation.
研究者
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