ReVENT Sleep Apnea System, a Minimally Invasive Approach to treat Obstructive Sleep Apnea: a Prospective Multicenter Post-Marketing Observational Study - REV 002 Observational study

ReVENT Medical International BV0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•1. Patient is 18 years of age or older.
•2. Patient diagnosed with Obstructive Sleep Apnea due to primary tongue base closure, which may benefit from the ReVENT Sleep Apnea System as per physician*s judgment within the intended use as described in the approved Instructions for Use.
•3. Patient with AHI * 10 and AHI *40 during sleep (at least 80% of apneas and hypopneas must be obstructive and at least 20% sleep time must be supine).
•4. Patient with BMI * 32.
•5. Patient must have been offered CPAP treatment as per National Guidelines and have refused or failed to continue CPAP.
•6. Drug Induced Sleep Endoscopy (DISE) will be performed in each patient to determine the site of upper airway collapse: patients must have tongue-based upper airway closure as defined by the VOTE criteria and without any of the following:
•a. complete concentric palatal collapse
•b. complete isolated epiglottis collapse (i.e., complete epiglottal collapse which does not involve the tongue or lateral walls collapsing in on it)
•c. any other anatomy which in the opinion of the physician is not suited for ReVENT implantation
•7. Patient able to complete questionnaires and follow post-operative assessment procedures.
•8. Patient able to exercise free informed consent.

•1. Patient with prior tongue-based surgery (patient with prior minimally invasive radio-frequency tongue-based procedures can be enrolled, but see below).
•2. Uvulopalatopharyngoplasty, soft palate surgery or tonsillectomy or minimally ablation of the tongue within six (6) months of the index procedure.
•3. History of mandibular and/or hyoid advancement to treat OSA.
•4. Any contraindications as listed in the approved Instructions for Use:
•a. Patient with enlarged tonsils (3+ and 4+)
•b. Patient with anatomy of the oral cavity or tongue unable to accommodate the implant
•c. Patient with significant rhinitis/nasal obstruction
•d. Patient with history of or ongoing diagnosis of dysphagia
•5. Other sleep-related conditions such as Restless Leg Syndrome, REM Behavior Disorder, insomnia or any neuromuscular disease affecting the tongue.
•6. Any patient with a history of substance abuse who cannot discontinue alcohol use for 24 hours prior to surgery.
•7. Patient with Diabetes type I.
•8. Any condition which in the judgment of the investigator would prevent the patient from completing the study.
•9. Existing or planned pregnancy during the course of the study.

发起方

ReVENT Medical International BV