[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cryosa, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100516753","clinical-trial-of-the-cryosa-system-for-the-treatment-of-obstructive-sleep-apnea-100516753",false,"NCT06008626","Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea","Multicenter Pilot Study of the Cryosa System for the Treatment of Obstructive Sleep Apnea","ARCTIC-3","Inclusion Criteria:\n\n1. To participate in this study, the subject must meet ALL of the following inclusion criteria:\n2. Age 22 - 70 years\n3. Not able to use, refuse to use or intolerant of Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) if using, must be \\\u003C 4 hours per night, \\\u003C 5 days\u002Fweek.\n4. Failed, are not candidates for, or have refused other invasive procedures such as hypoglossal nerve stimulation or pharmacotherapy for the primary treatment of OSA such as Tirzepatide.\n5. BMI ≥30 or ≤ 40 kg\u002Fm2 at enrollment\n6. 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 Is geographically stable and in close proximity to the site\n7. Able and willing to provide written consent to participate in the study\n\nExclusion Criteria:\n\n1. Contraindication to general anesthesia or in the opinion of the Investigator would not be able to tolerate the procedure, including intubation during the procedure or in response to an adverse event\n2. Actively taking ACEs\u002FARBs\n3. Actively undergoing immunotherapy (Allergy shots)\\*, or unwilling to washout of allergy shots at least 2 weeks prior to study procedure.\n\n   \\* Patients receiving immunotherapy may be eligible if they undergo a 2-week wash-out prior to the study procedure\n4. Severe uncontrolled asthma\n5. Severe maxillary mandibular insufficiency that in the opinion of the investigator thought to be the primary cause of OSA\n6. Obvious severe fixed upper airway obstructions (tumors, polyps, nasal obstruction)\n7. Previous surgery within 12 weeks of scheduled procedure performed on the soft tissue of the upper airway (e.g., uvula, soft palate, or tonsils).\n8. Oral cancer or non-healing oral wounds\n9. Prior sleep surgeries, including tongue base reduction, UPPP and hypoglossal nerve stimulation.\n10. History of radiation therapy to neck or upper respiratory tract\n11. Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat (with exception of tonsillectomy and\u002For adenoidectomy)\n12. History presence of cold urticaria at the time of screening History of cryoglobulinemia\n13. History of allergy to glycerin\n14. History of hospitalization with mechanical ventilation due to COVID-19 per investigator discretion\n15. 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\n16. Patients with diagnosed autoimmune disorders including thyroid disease, lupus, multiple myeloma, chronic lymphocytic leukemia\n17. Neuromuscular disease or other neurologic deficits (for example multiple sclerosis, muscular dystrophy, Parkinson's disease, transient ischemic attack, epilepsy or cerebrovascular accident)\n18. Diagnosis of any moderate to severe congestive obstructive pulmonary disease (COPD)\n19. Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism) History of angioedema of the airway\n20. Hereditary angioedema and other autoimmune disorders that could lead to acquired angioedema - confirmed with a compliment component C4 blood test \\\u003C13mg\u002FdL.\n21. Uncontrolled Diabetes (including Diabetes Mellitus \\[DM\\] or Insulin Dependent Diabetes Mellitus \\[IDDM\\]) with HbA1c \\>9.\n22. Currently receiving treatment for severe cardiac valvular dysfunction, NYHA Class III or IV heart failure, unstable angina or recent (\\\u003C 12 months) myocardial infarction or severe cardiac arrhythmias\n23. Subjects with bleeding event, known bleeding diathesis, impaired immunity for any reason, or heart attack or stroke within the last 12 months\n24. Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 6 months\n25. History or current clinical evidence of TIA or stroke or muscular dysfunction\n26. Current smoker (≥ 1 pack\u002Fday)\n27. Presence of occupational shift work or anticipation of shift changes during the next 2 years\n28. Subject has sleep hygiene behavior that is likely to interfere with measurement outcomes during PSG and\u002For HSAT\n29. Known active substance use disorder\n30. Other severe sleep disorders that in the opinion of the investigator, confound functional assessments of sleepiness such as narcolepsy with cataplexy, severe insomnia\u002Finsomnia secondary to chronic pain, PTSD\n31. 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)\n32. 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\n33. Females who are pregnant or females of childbearing age with intention to become pregnant during the study period (≤ 3 months from treatment date)\n34. Any other reason the investigator deems subject is unfit for participation in the study\n35. Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing","ALL","22 Years","70 Years",{"count":21,"type":22},25,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28],"Obstructive Sleep Apnea of Adult","RECRUITING","2026-04-27",{"date":32,"type":33},"2026-04-30","ACTUAL",{"date":35,"type":33},"2023-09-12",{"date":37,"type":22},"2028-06-30",{"name":39,"class":40},"Cryosa, Inc.","INDUSTRY",9,{"id":43,"slug":4,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":48,"targetDuration":4,"studyType":23,"phases":50,"briefSummary":26,"conditions":51,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":4},"100594621","NCT07021833","Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea (ARCTIC_AUS)","Multicenter Pilot Study of the Cryosa System for the Treatment of Obstructive Sleep Apnea (ARCTIC_AUS)","Inclusion Criteria:\n\n1. Willing and capable of providing informed consent\n2. Willing and capable of receiving the study procedure and returning for all follow-up evaluations and sleep studies\n3. Willing and capable of completing all questionnaires\n4. Age is 22 to 70 years old\n5. Not able to use, refuse to use, or intolerant of Positive Airway Pressure (PAP) or Mandibular Advancement Devices (MAD)\n6. BMI of ≤ 40 kg\u002Fm2 at enrollment\n7. 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\n\nExclusion Criteria:\n\nGeneral Exclusions\n\n1. Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing\n2. Any reason the investigator deems the subject unfit for participation in the study\n\n   Concomitant Medication Exclusions\n3. Actively taking ACEs\u002FARBs for hypertension AND is either of black race, of female gender or \\>65 years of age\n4. Actively undergoing immunotherapy (Allergy shots), or unwilling to washout of allergy shots at least 2 weeks prior to study procedure\n5. 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)\n6. Currently on stable GLP-1 medication dosing and unwilling to commit to maintaining that dose until completion of the 6-month assessment post-procedure.\n7. 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\n\n   Medical History Exclusions\n8. Prior sleep surgeries, including tongue base reduction or palatoplasty (with exception of tonsillectomy and\u002For adenoidectomy)\n9. 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)\n10. Patients with severe, uncontrolled asthma\n11. History of angioedema\u002Fswelling of the airway\n12. Hereditary angioedema and other autoimmune disorders that could lead to acquired angioedema confirmed with a compliment component C4 blood test \\\u003C13mg\u002FdL\n13. History or presence of cold urticaria at the time of screening\n14. History of cryoglobulinemia\n15. History of allergy to glycerin\n16. Diagnosed autoimmune disorders including active thyroid disease, lupus, multiple myeloma, chronic lymphocytic leukemia\n17. Oral cancer or non-healing oral wounds\n18. History of radiation therapy to neck or upper respiratory tract\n19. Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat (with exception of tonsillectomy and\u002For adenoidectomy)\n20. 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\n21. Neuromuscular disease or other neurologic deficits (for example multiple sclerosis, muscular dystrophy, Parkinson's disease, transient ischemic attack, epilepsy or cerebrovascular accident)\n22. Diagnosis of any moderate to severe congestive obstructive pulmonary disease (COPD)\n23. Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism)\n24. Uncontrolled Diabetes (including Diabetes Mellitus \\[DM\\] or Insulin Dependent Diabetes Mellitus \\[IDDM\\]) with HbA1c \\>9\n25. Currently receiving treatment for severe cardiac valvular dysfunction, NYHA Class III or IV heart failure, unstable angina or recent (\\\u003C 12 months) myocardial infarction or severe cardiac arrhythmias\n26. Subjects with bleeding event, known bleeding diathesis, impaired immunity for any reason, or heart attack or stroke within the last 12 months\n27. Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 6 months\n28. History or current clinical evidence of TIA or stroke or muscular dysfunction\n29. Other severe sleep disorders that in the opinion of the investigator, confound functional assessments of sleepiness such as narcolepsy with cataplexy, severe insomnia\u002Finsomnia secondary to chronic pain, PTSD\n30. 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\n\n    Lifestyle \u002F Work\n31. Current smoker (≥ 1 pack\u002Fday)\n32. Presence of occupational shift work or anticipation of shift changes during the study duration\n33. Subject has sleep hygiene behavior that is likely to interfere with measurement outcomes during PSG.\n34. Known active substance use disorder\n35. 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)\n36. Unwilling or unable to refrain from and washout use of oral appliances or positional devices for the PSG sleep studies.\n37. 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\n38. Subject has an occupation for which untreated OSA presents a substantial risk to safety\n39. 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.\n\n    Upper Airway Exam\n40. Severe maxillary mandibular insufficiency that in the opinion of the investigator thought to be the primary cause of OSA\n41. Obvious severe fixed upper airway obstructions (tumors, polyps, nasal obstruction)\n42. Obstructions identified at the tonsils (palatine tonsils size 3+ or 4+)\n43. Lingual tonsils size 4+\n44. Friedman tongue position IV\n\n    Surgical Consult\n45. Contraindication to general anesthesia or in the opinion of the Investigator would not be able to tolerate the procedure, including intubation during the procedure\n46. Any reason for which, in the judgment of the investigator, the subject is considered to be a poor surgical or study candidate, which may include, but is not limited to: any medical, anatomical, social, or psychological problems that could complicate the procedure and\u002For recovery from the procedure or could complicate the required procedures and evaluations of the study\n\n    PSG Exclusion Criteria\n47. ≥ 25% Central and mixed apnea and hypopnea events as a proportion of the sum of apnea and hypopnea events per hour\n48. Oxygen saturation must be ≥ 70% for ≥ 90% of time during sleep.\n49. Non-supine AHI \\\u003C 10, minimum of 45 minutes non-supine sleep time\n50. Failure to complete a 72-hour CPAP washout period before administering the PSG and unwilling to repeat",{"count":49,"type":22},30,[25],[52],"Obstructive Sleep Apnea (OSA)","NOT_YET_RECRUITING","2025-06-06",{"date":56,"type":33},"2025-06-15",{"date":58,"type":22},"2025-08",{"date":60,"type":22},"2027-02",{"name":39,"class":40},""]