NCT07021833撤回不适用
Multicenter Pilot Study of the Cryosa System for the Treatment of Obstructive Sleep Apnea (ARCTIC_AUS)
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Cryosa, Inc.
- 入组人数
- 30
- 主要终点
- Incidence of Serious Procedure or Device/Treatment Related Events
研究概览
简要总结
This is a prospective, multicenter, non-randomized single-arm safety and performance study to collect data to evaluate the safety of the Cryosa procedure to treat obstructive sleep apnea (OSA) in patients with moderate to severe OSA. The study will also evaluate the chronic performance of the Cryosa system and collect clinical measures for therapy effectiveness that will be used to demonstrate safety and effectiveness in the next clinical study.
详细描述
The study will treat up to 30 subjects at up to 5 sites in Australia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and capable of providing informed consent
- •Willing and capable of receiving the study procedure and returning for all follow-up evaluations and sleep studies
- •Willing and capable of completing all questionnaires
- •Age is 22 to 70 years old
- •Not able to use, refuse to use, or intolerant of Positive Airway Pressure (PAP) or Mandibular Advancement Devices (MAD)
- •BMI of ≤ 40 kg/m2 at enrollment
- •AHI >=30 at enrollment based on in-lab polysomnography study OR AHI ≥ 15 and BMI of >= 30 at enrollment based on in-lab polysomnography study
排除标准
- •General Exclusions
- •Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing
- •Any reason the investigator deems the subject unfit for participation in the study
- •Concomitant Medication Exclusions
- •Actively taking ACEs/ARBs for hypertension AND is either of black race, of female gender or >65 years of age
- •Actively undergoing immunotherapy (Allergy shots), or unwilling to washout of allergy shots at least 2 weeks prior to study procedure
- •Patients taking any of the following medication that could affect study endpoints: benzodiazepines, Z-drugs (zolpidem and eszopiclone) opiates, antipsychotics (neuroleptics), phenothiazines, and prescription stimulants (including Sunosi, Provigil, and Nuvigil)
- •Currently on stable GLP-1 medication dosing and unwilling to commit to maintaining that dose until completion of the 6-month assessment post-procedure.
- •Currently titrating GLP-1 medication and unwilling to discontinue use 1 month prior to procedure date and commit to not to re-start until completion of the 6-month assessment post-procedure
- •Medical History Exclusions
- •Prior sleep surgeries, including tongue base reduction or palatoplasty (with exception of tonsillectomy and/or adenoidectomy)
- •Previous surgery (non-OSA) within 12 weeks of scheduled procedure performed on the soft tissue of the upper airway (e.g., uvula, soft palate, or tonsils)
- •Patients with severe, uncontrolled asthma
- •History of angioedema/swelling of the airway
- •Hereditary angioedema and other autoimmune disorders that could lead to acquired angioedema confirmed with a compliment component C4 blood test <13mg/dL
- •History or presence of cold urticaria at the time of screening
- •History of cryoglobulinemia
- •History of allergy to glycerin
- •Diagnosed autoimmune disorders including active thyroid disease, lupus, multiple myeloma, chronic lymphocytic leukemia
- •Oral cancer or non-healing oral wounds
- •History of radiation therapy to neck or upper respiratory tract
- •Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat (with exception of tonsillectomy and/or adenoidectomy)
- •Resistant hypertension, defined as a blood pressure that remains above goal despite concurrent use of three antihypertensive agents of different classes taken at maximally tolerated doses
- •Neuromuscular disease or other neurologic deficits (for example multiple sclerosis, muscular dystrophy, Parkinson's disease, transient ischemic attack, epilepsy or cerebrovascular accident)
- •Diagnosis of any moderate to severe congestive obstructive pulmonary disease (COPD)
- •Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism)
- •Uncontrolled Diabetes (including Diabetes Mellitus [DM] or Insulin Dependent Diabetes Mellitus [IDDM]) with HbA1c >9
- •Currently receiving treatment for severe cardiac valvular dysfunction, NYHA Class III or IV heart failure, unstable angina or recent (< 12 months) myocardial infarction or severe cardiac arrhythmias
- •Subjects with bleeding event, known bleeding diathesis, impaired immunity for any reason, or heart attack or stroke within the last 12 months
- •Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 6 months
- •History or current clinical evidence of TIA or stroke or muscular dysfunction
- •Other severe sleep disorders that in the opinion of the investigator, confound functional assessments of sleepiness such as narcolepsy with cataplexy, severe insomnia/insomnia secondary to chronic pain, PTSD
- •Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject's ability to meet study requirements and ability to provide study consent
- •Lifestyle / Work
- •Current smoker (≥ 1 pack/day)
- •Presence of occupational shift work or anticipation of shift changes during the study duration
- •Subject has sleep hygiene behavior that is likely to interfere with measurement outcomes during PSG.
- •Known active substance use disorder
- •Females who are pregnant or females of childbearing age with intention to become pregnant during the study period (period defined as ≤ 3 months from treatment date)
- •Unwilling or unable to refrain from and washout use of oral appliances or positional devices for the PSG sleep studies.
- •Unwilling or unable to refrain from use of PAP, oral appliances for OSA, OSA surgery, or medications for OSA from enrollment through the completion of the Month 6 follow-up visit
- •Subject has an occupation for which untreated OSA presents a substantial risk to safety
- •Residing at or is planning to move within 2 years to a location where the subject would no longer be willing or capable of returning for all follow-up evaluations and sleep studies.
- •Upper Airway Exam
- •Severe maxillary mandibular insufficiency that in the opinion of the investigator thought to be the primary cause of OSA
- •Obvious severe fixed upper airway obstructions (tumors, polyps, nasal obstruction)
- •Obstructions identified at the tonsils (palatine tonsils size 3+ or 4+)
- •Lingual tonsils size 4+
- •Friedman tongue position IV
- •Surgical Consult
- 另有 7 项未显示
研究组 & 干预措施
Cryosa Procedure
Experimental
干预措施: Cryosa Procedure (Device)
结局指标
主要结局
Incidence of Serious Procedure or Device/Treatment Related Events
时间窗: 90 days post procedure
Safety will be assessed by evaluating all serious procedure- or device/treatment-related events occurring in the first 90 days post-procedure
次要结局
未报告次要终点
研究者
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