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

NCT04864652 | Completed FDA Device

• 1 other identifier: 10419
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (1)

• Incidence of Serious Procedure-Related Complications

  No serious procedure-related complications including death, loss of the airway requiring post-anesthesia care unit (PACU) re-intubation, persistent loss (more than 30 days) of tongue movement, or bleeding requiring surgical intervention or transfusion.

  30 Days

Study Arms (1)

Single Arm

EXPERIMENTAL

CHILLS Procedure

Device: CHILLS Procedure

Interventions

CHILLS Procedure DEVICE

CHILLS Cryotherapy procedure

Single Arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Presence of symptoms of influenza-like symptoms.
• Contra-indicated for anesthesia or surgery.
• History of surgery affecting the tongue (TORS, semi-glossectomy, RFBOT, MMA, HGNS).
• 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).
• Clinical evidence of severe chronic obstructive or restrictive pulmonary disease (for example chronic bronchitis, emphysema, pulmonary fibrosis).
• Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism).

Sponsors & Collaborators

• Cryosa, Inc.: lead

Study Sites (2)

Paitilla Medical Center

Panama City, Panama

Location

Sanatorio Americano

Asunción, Paraguay

Location

Study Officials

• Marquito Caballero, MD

  Sanatorio Americano

  PRINCIPAL INVESTIGATOR

• Stella Rowley, MD

  San Fernando Specialized Center

  PRINCIPAL INVESTIGATOR

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: March 17, 2021
• First Posted: April 29, 2021
• Study Start: November 30, 2020
• Primary Completion: August 25, 2022
• Study Completion: May 6, 2023
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)