CompletedNot Applicable

Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of OSA

Panama, Paraguay84 participantsStarted 2020-11-30

Plain-language summary

ARCTIC-1 is a safety and dosing study to evaluate procedure tolerability in patients with clinically diagnosed moderate or severe OSA.

Age range22 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age 25 - 65 years.
✓. Diagnosed with moderate to severe OSA based on history and physical or have an established diagnosis of OSA (AHI ≥ 15 and ≤ 50) based on a prior sleep study.
✓. BMI is between 28 kg/m2 and 40 kg/m2 at enrollment.
✓. Negative result for COVID-19 polymerase chain reaction (RT-PCR) test and absence of clinical symptoms for COVID-19.

✕. Subjects with a high percentage of central apneas suggesting heart failure.
✕. Contraindication to general anesthesia and MRI.
✕. Metal braces, plate or pieces in the head or jaw that may interfere with MRI.
✕. Craniofacial abnormality (e.g. retrognathia, micrognathia, etc.) thought to be the primary cause of OSA.
✕. Obvious fixed upper airway obstructions (tumors, polyps, nasal obstruction) .
✕. Tonsil size ≥ +3.
✕. 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.

Incidence of Serious Procedure-Related Complications

Timeframe: 30 Days

NCT IDNCT04864652

SponsorCryosa, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-25