xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06008626</url>
    </required_header>
    <id_info>
      <org_study_id>11515</org_study_id>
      <nct_id>NCT06008626</nct_id>
    </id_info>
    <brief_title>Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea</brief_title>
    <acronym>ARCTIC-3</acronym>
    <official_title>Multicenter Pilot Study of the Cryosa System for the Treatment of Obstructive Sleep Apnea</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cryosa, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cryosa, Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective, multicenter, non-randomized single-arm safety and performance study to&#xD;
        collect data to evaluate the safety of the Cryosa procedure to treat obstructive sleep apnea&#xD;
        (OSA) in patients with moderate to severe OSA. The study will also evaluate the chronic&#xD;
        performance of the Cryosa system and collect clinical measures for therapy effectiveness that&#xD;
        will be used to demonstrate safety and effectiveness in the next clinical study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will treat 25 subjects enrolled at up to 10 sites in the United States. Enrollment&#xD;
        is competitive but each site will be limited to 15 subjects treated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 12, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2029</completion_date>
    <primary_completion_date type="Anticipated">September 29, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of Serious Procedure or Device/ Treatment Related Events</measure>
      <time_frame>First 90 days post-procedure</time_frame>
      <description>Safety will be assessed by evaluating all serious procedure- or device/treatment-related events occurring in the first 90 days post-procedure.&#xD;
  Adverse events (AE), both serious and non-serious, related and unrelated, will be collected from all subjects enrolled for the duration of the study.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sleep Testing</measure>
      <time_frame>6 Month Follow-up Visit</time_frame>
      <description>Quantify the effect of the Cryosa procedure in reducing the severity of OSA post-procedure by evaluating the change from baseline in the apnea hypopnea index (AHI4) with polysomnography (PSG) testing.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Reported Outcomes (PRO) Efficacy Measures - Epworth Sleepiness Survey (ESS)</measure>
      <time_frame>30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure</time_frame>
      <description>Evaluate change in daytime sleepiness after treatment compared to baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Reported Outcomes (PRO) Efficacy Measures - Functional Outcomes of Sleep Questionnaire (FOSQ)</measure>
      <time_frame>30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure</time_frame>
      <description>Evaluate the change of impact of daytime sleepiness on activities of daily living after treatment compared to baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Reported Outcomes (PRO) Safety Measures - Pain Numeric Scale (NRS)</measure>
      <time_frame>7 Days, 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure</time_frame>
      <description>Evaluate oropharyngeal pain metrics after treatment compared to baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Reported Outcomes (PRO) Safety Measures - Eating Assessment Tool (EAT-10)</measure>
      <time_frame>7 Days, 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure</time_frame>
      <description>Evaluate change in swallowing metrics after treatment compared to baseline.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Home Sleep Apnea Testing (HSAT) - Apnea-Hypopnea Index (AHI4)</measure>
      <time_frame>90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure</time_frame>
      <description>Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in AHI4 after treatment compared to baseline.</description>
    </other_outcome>
    <other_outcome>
      <measure>Home Sleep Apnea Testing (HSAT) - Oxygen Desaturation Index (ODI)</measure>
      <time_frame>90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure</time_frame>
      <description>Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in ODI sleep metrics after treatment compared to baseline.</description>
    </other_outcome>
    <other_outcome>
      <measure>Home Sleep Apnea Testing (HSAT) - Oxygen Saturation (SpO2)</measure>
      <time_frame>90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure</time_frame>
      <description>Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in SpO2 sleep metrics after treatment compared to baseline.</description>
    </other_outcome>
    <other_outcome>
      <measure>Home Sleep Apnea Testing (HSAT) - Hypoxic Burden</measure>
      <time_frame>90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure</time_frame>
      <description>Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in hypoxic burden sleep metrics after treatment compared to baseline.</description>
    </other_outcome>
    <other_outcome>
      <measure>Home Sleep Apnea Testing (HSAT) - Snoring</measure>
      <time_frame>90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure</time_frame>
      <description>Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in snoring episodes sleep metrics after treatment compared to baseline.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Obstructive Sleep Apnea of Adult</condition>
    <arm_group>
      <arm_group_label>Cryosa Procedure</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The purpose of this study is to evaluate the safety and effectiveness of Cryosa System applied to the tongue and soft palate in patients with clinically diagnosed obstructive sleep apnea (OSA).</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Cryosa Procedure</intervention_name>
      <description>Cryotherapy</description>
      <arm_group_label>Cryosa Procedure</arm_group_label>
      <other_name>OSA Cryotreatment</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 22 - 70 years&#xD;
  &#xD;
            2. Likely suffer moderate to severe OSA based on history and physical or have an&#xD;
               established diagnosis of moderate to severe OSA (AHI ≥ 15) based on a prior sleep&#xD;
               study. PSG will be performed after enrollment, or an acceptable PSG performed within 3&#xD;
               months of enrollment is required, to verify a) AHI ≥ 15 b) mixed and central apneas&#xD;
               total ≤ 25% of apneas, and c) SpO2 must be ≥ 70% for ≥ 90% of sleep time for continued&#xD;
               eligibility.&#xD;
  &#xD;
            3. Not able to use, refuse to use or intolerant of Positive Airway Pressure (PAP) or&#xD;
               Mandibular Advancement Device (MAD)&#xD;
  &#xD;
            4. BMI of ≤ 40 kg/m2 at enrollment&#xD;
  &#xD;
            5. Is geographically stable and in close proximity to the site&#xD;
  &#xD;
            6. Able and willing to provide written consent to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Contraindication to general anesthesia or in the opinion of the Investigator would not&#xD;
               be able to tolerate the procedure, including intubation during the procedure or in&#xD;
               response to an adverse event&#xD;
  &#xD;
            2. Severe maxillary mandibular insufficiency that in the opinion of the investigator&#xD;
               thought to be the primary cause of OSA&#xD;
  &#xD;
            3. Obvious severe fixed upper airway obstructions (tumors, polyps, nasal obstruction)&#xD;
  &#xD;
            4. Previous surgery within 12 weeks of scheduled procedure performed on the soft tissue&#xD;
               of the upper airway (e.g., uvula, soft palate, or tonsils).&#xD;
  &#xD;
            5. Oral cancer or non-healing oral wounds&#xD;
  &#xD;
            6. Prior sleep surgeries, including tongue base reduction, UPPP and hypoglossal nerve&#xD;
               stimulation.&#xD;
  &#xD;
            7. History of radiation therapy to neck or upper respiratory tract&#xD;
  &#xD;
            8. Surgical resection for cancer or congenital malformations in the larynx, tongue, or&#xD;
               throat (with exception of tonsillectomy and/or adenoidectomy)&#xD;
  &#xD;
            9. History of cold urticaria&#xD;
  &#xD;
           10. History of hospitalization with mechanical ventilation due to COVID-19 per&#xD;
               investigator discretion&#xD;
  &#xD;
           11. Resistant hypertension defined as a blood pressure that remains above goal despite&#xD;
               concurrent use of three antihypertensive agents of different classes taken at&#xD;
               maximally tolerated doses&#xD;
  &#xD;
           12. Neuromuscular disease or other neurologic deficits (for example multiple sclerosis,&#xD;
               muscular dystrophy, Parkinson's disease, transient ischemic attack, epilepsy or&#xD;
               cerebrovascular accident)&#xD;
  &#xD;
           13. Diagnosis of any moderate to severe congestive obstructive pulmonary disease (COPD)&#xD;
  &#xD;
           14. Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension&#xD;
               or pulmonary embolism)&#xD;
  &#xD;
           15. Untreated, active thyroid disease such as Hashimoto Thyroiditis that may cause&#xD;
               angioedema or enlargement of the tongue&#xD;
  &#xD;
           16. History of angioedema of the tongue&#xD;
  &#xD;
           17. Uncontrolled Diabetes (including Diabetes Mellitus [DM] or Insulin Dependent Diabetes&#xD;
               Mellitus [IDDM]) with HbA1c &gt;9.&#xD;
  &#xD;
           18. Currently receiving treatment for severe cardiac valvular dysfunction, NYHA Class III&#xD;
               or IV heart failure, unstable angina or recent (&lt; 12 months) myocardial infarction or&#xD;
               severe cardiac arrhythmias&#xD;
  &#xD;
           19. Subjects with bleeding event, known bleeding diathesis, impaired immunity for any&#xD;
               reason, or heart attack or stroke within the last 12 months&#xD;
  &#xD;
           20. Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or&#xD;
               expected to institute dialysis within 6 months&#xD;
  &#xD;
           21. History or current clinical evidence of TIA or stroke or muscular dysfunction&#xD;
  &#xD;
           22. Current smoker (≥ 1 pack/day)&#xD;
  &#xD;
           23. Presence of occupational shift work or anticipation of shift changes during the next 2&#xD;
               years&#xD;
  &#xD;
           24. Subject has sleep hygiene behavior that is likely to interfere with measurement&#xD;
               outcomes during PSG and/or HSAT&#xD;
  &#xD;
           25. Known active substance use disorder&#xD;
  &#xD;
           26. Other severe sleep disorders that in the opinion of the investigator, confound&#xD;
               functional assessments of sleepiness such as narcolepsy with cataplexy, severe&#xD;
               insomnia/insomnia secondary to chronic pain, PTSD&#xD;
  &#xD;
           27. Patients taking any of the following medication that could affect study endpoints:&#xD;
  &#xD;
               benzodiazepines, Z-drugs (zolpidem and eszopiclone) opiates, antipsychotics&#xD;
               (neuroleptics), phenothiazines, and prescription stimulants (including Sunosi,&#xD;
               Provigil, and Nuvigil)&#xD;
  &#xD;
           28. Active psychiatric disease (psychotic illness, major depression, or acute anxiety&#xD;
               attacks) which prevents subject's ability to meet study requirements and ability to&#xD;
               provide study consent&#xD;
  &#xD;
           29. Females who are pregnant or females of childbearing age with intention to become&#xD;
               pregnant during the study period (≤ 3 months from treatment date)&#xD;
  &#xD;
           30. Any other reason the investigator deems subject is unfit for participation in the&#xD;
               study&#xD;
  &#xD;
           31. Subject currently participating in other premarket investigational studies unless&#xD;
               approved by Sponsor in writing&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Kristine Selander</last_name>
      <phone>763-267-3202</phone>
      <email>kselander@cryosa.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Beth Duff</last_name>
      <phone>612-968-7014</phone>
      <email>bduff@cryosa.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Albany ENT &amp; Allergy Services</name>
        <address>
          <city>Albany</city>
          <state>New York</state>
          <zip>12205</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Julie Baum, LPN</last_name>
        <phone>501-701-2085</phone>
        <email>jbaum@albanyentandallergy.com</email>
      </contact>
      <investigator>
        <last_name>Gavin Setzen, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Siobhan Kuhar, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Nora Perkins, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Apnea</mesh_term>
      <mesh_term>Sleep Apnea Syndromes</mesh_term>
      <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06008626
  org study id: 11515
  nct id: NCT06008626
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: Yes
  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.
  The study will treat 25 subjects enrolled at up to 10 sites in the United States. Enrollment
        is competitive but each site will be limited to 15 subjects treated.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of Serious Procedure or Device/ Treatment Related Events
  time frame: First 90 days post-procedure
  description: Safety will be assessed by evaluating all serious procedure- or device/treatment-related events occurring in the first 90 days post-procedure.
  Adverse events (AE), both serious and non-serious, related and unrelated, will be collected from all subjects enrolled for the duration of the study.
  measure: Sleep Testing
  time frame: 6 Month Follow-up Visit
  description: Quantify the effect of the Cryosa procedure in reducing the severity of OSA post-procedure by evaluating the change from baseline in the apnea hypopnea index (AHI4) with polysomnography (PSG) testing.
  measure: Patient Reported Outcomes (PRO) Efficacy Measures - Epworth Sleepiness Survey (ESS)
  time frame: 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
  description: Evaluate change in daytime sleepiness after treatment compared to baseline.
  measure: Patient Reported Outcomes (PRO) Efficacy Measures - Functional Outcomes of Sleep Questionnaire (FOSQ)
  time frame: 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
  description: Evaluate the change of impact of daytime sleepiness on activities of daily living after treatment compared to baseline.
  measure: Patient Reported Outcomes (PRO) Safety Measures - Pain Numeric Scale (NRS)
  time frame: 7 Days, 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
  description: Evaluate oropharyngeal pain metrics after treatment compared to baseline.
  measure: Patient Reported Outcomes (PRO) Safety Measures - Eating Assessment Tool (EAT-10)
  time frame: 7 Days, 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
  description: Evaluate change in swallowing metrics after treatment compared to baseline.
  measure: Home Sleep Apnea Testing (HSAT) - Apnea-Hypopnea Index (AHI4)
  time frame: 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
  description: Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in AHI4 after treatment compared to baseline.
  measure: Home Sleep Apnea Testing (HSAT) - Oxygen Desaturation Index (ODI)
  time frame: 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
  description: Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in ODI sleep metrics after treatment compared to baseline.
  measure: Home Sleep Apnea Testing (HSAT) - Oxygen Saturation (SpO2)
  time frame: 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
  description: Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in SpO2 sleep metrics after treatment compared to baseline.
  measure: Home Sleep Apnea Testing (HSAT) - Hypoxic Burden
  time frame: 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
  description: Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in hypoxic burden sleep metrics after treatment compared to baseline.
  measure: Home Sleep Apnea Testing (HSAT) - Snoring
  time frame: 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
  description: Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in snoring episodes sleep metrics after treatment compared to baseline.
  arm group label: Cryosa Procedure
  arm group type: Experimental
  description: The purpose of this study is to evaluate the safety and effectiveness of Cryosa System applied to the tongue and soft palate in patients with clinically diagnosed obstructive sleep apnea (OSA).
  intervention type: Device
  intervention name: Cryosa Procedure
  description: Cryotherapy
  arm group label: Cryosa Procedure
  other name: OSA Cryotreatment
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Kristine Selander
  phone: 763-267-3202
  email: kselander@cryosa.com
  last name: Beth Duff
  phone: 612-968-7014
  email: bduff@cryosa.com
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Apnea
  mesh term: Sleep Apnea Syndromes
  mesh term: Sleep Apnea, Obstructive
  sharing ipd: No