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

NCT04864652 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-06-26

No results posted yet for this study

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

Interventions

DEVICE

CHILLS Procedure

CHILLS Cryotherapy procedure

Sponsors & Collaborators

  • Cryosa, Inc.

    lead INDUSTRY

Principal Investigators

  • Marquito Caballero, MD · Sanatorio Americano

  • Stella Rowley, MD · San Fernando Specialized Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2022-08-25
Completion
2023-05-06
FDA Device
Yes

Countries

  • Panama
  • Paraguay

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04864652 on ClinicalTrials.gov