Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea

NCT06008626 | Recruiting DMC FDA Device

• 1 other identifier: 11515
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Obstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (1)

• Incidence of Serious Procedure or Device/ Treatment Related Events

  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.

  First 90 days post-procedure

Secondary Outcomes (6)

• Sleep Testing

  6 Month Follow-up Visit

• Patient Reported Outcomes (PRO) Efficacy Measures - Epworth Sleepiness Survey (ESS)

  30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure

• Patient Reported Outcomes (PRO) Safety Measures - Pain Numeric Scale (NRS)

  7 Days, 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure

• Patient Reported Outcomes (PRO) Safety Measures - Eating Assessment Tool (EAT-10)

  7 Days, 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure

• Patient Reported Outcomes (PRO) Safety Measures - PROMIS-Sleep Disturbance (PROMIS-SD)

  30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure

Other Outcomes (5)

• Home Sleep Apnea Testing (HSAT) - Apnea-Hypopnea Index (AHI4)

  90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure

• Home Sleep Apnea Testing (HSAT) - Oxygen Desaturation Index (ODI)

  90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure

• Home Sleep Apnea Testing (HSAT) - Oxygen Saturation (SpO2)

  90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure

Study Arms (1)

Cryosa Procedure

EXPERIMENTAL

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).

Device: Cryosa Procedure

Interventions

Cryosa Procedure DEVICE

Cryotherapy

Also known as: OSA Cryotreatment

Cryosa Procedure

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 22 - 70 years
• Not able to use, refuse to use or intolerant of Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) if using, must be \< 4 hours per night, \< 5 days/week.
• 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.
• BMI ≥30 or ≤ 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 Is geographically stable and in close proximity to the site
• Able and willing to provide written consent to participate in the study

You may not qualify if:

• 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
• Actively taking ACEs/ARBs
• Actively undergoing immunotherapy (Allergy shots)\*, or unwilling to washout of allergy shots at least 2 weeks prior to study procedure.
• \* Patients receiving immunotherapy may be eligible if they undergo a 2-week wash-out prior to the study procedure
• Severe uncontrolled asthma
• 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)
• Previous surgery within 12 weeks of scheduled procedure performed on the soft tissue of the upper airway (e.g., uvula, soft palate, or tonsils).
• Oral cancer or non-healing oral wounds
• Prior sleep surgeries, including tongue base reduction, UPPP and hypoglossal nerve stimulation.
• 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)
• History presence of cold urticaria at the time of screening History of cryoglobulinemia
• History of allergy to glycerin
• History of hospitalization with mechanical ventilation due to COVID-19 per investigator discretion

Sponsors & Collaborators

• Cryosa, Inc.: lead

Study Sites (9)

UCHealth University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Ochsner Baptist Medical Center

New Orleans, Louisiana, 70115, United States

RECRUITING

Albany ENT & Allergy Services

Albany, New York, 12205, United States

RECRUITING

Specialty Physician Associates

Bethlehem, Pennsylvania, 18017, United States

ACTIVE NOT RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Tennessee Health Sciences Center

Memphis, Tennessee, 38163, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

Central Study Contacts

Laura Stoltenberg

CONTACT

612-489-5909; lstoltenberg@cryosa.com

Cassie Morris

CONTACT

612-489-5909; cmorris@cryosa.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 23, 2023
• Study Start: September 12, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)