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Pilot Study of the CHILLS Cryotherapy System for the Treatment of OSA (ARCTIC-2)

Primary Purpose

Obstructive Sleep Apnea of Adult

Status
Recruiting
Phase
Not Applicable
Locations
Panama
Study Type
Interventional
Intervention
CHILLS Procedure
Sponsored by
Cryosa, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea of Adult

Eligibility Criteria

22 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Likely suffer moderate to severe OSA based on history and physical or have an established diagnosis of moderate to severe OSA (AHI ≥ 10) based on a prior sleep study.

A confirmation baseline sleep study will be performed after enrollment to verify AHI ≥ 10 and ≤ 50, and mixed and central apneas total ≤ 25% of apneas for continued eligibility.

Have either failed Positive Airway Pressure (PAP) therapy or decline PAP therapy

BMI of 25 - 40 kg/m2 at enrollment

Negative result for COVID-19 polymerase chain reaction (RT-PCR) test and absence of clinical symptoms for long COVID-19 relating to deterioration of taste, smell.

Exclusion Criteria:

Unable or incapable of providing informed written consent

Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires

Sites / Locations

  • Paitilla Medical CenterRecruiting
  • Punta Pacifica HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

CHILLS Procedure

Outcomes

Primary Outcome Measures

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; bleeding requiring surgical intervention or transfusion; device- or procedure-related hospital re-admission; or De novo clinically significant hypoxemia (immediate or delayed) with SpO2 < 70% for > 10% of sleep.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2022
Last Updated
September 13, 2022
Sponsor
Cryosa, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05542082
Brief Title
Pilot Study of the CHILLS Cryotherapy System for the Treatment of OSA
Acronym
ARCTIC-2
Official Title
OUS Multicenter Pilot Study of the CHILLS Cryotherapy System for the Treatment of Obstructive Sleep Apnea (ARCTIC-2)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
April 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cryosa, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective, multicenter, non-randomized single-arm safety and efficacy study to: Collect data to evaluate the safety of CHILLS cryotherapy to treat OSA in patients with moderate to severe disease. Evaluate the chronic performance of the CHILLS system and collect clinical measures for therapy effectiveness that will be used to demonstrate safety and effectiveness in the next clinical study.
Detailed Description
The study will enroll up to 3 sites in Latin America, enrollment is competitive. Up to 70 subjects will receive treatment and be followed through their 3-month visit. Long-term follow-up will continue every 6 months out to 2 years post-procedure, with an option to follow patients up to 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea of Adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
CHILLS Procedure
Intervention Type
Device
Intervention Name(s)
CHILLS Procedure
Intervention Description
Cryotherapy
Primary Outcome Measure Information:
Title
Incidence of Serious Procedure-Related Complications
Description
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; bleeding requiring surgical intervention or transfusion; device- or procedure-related hospital re-admission; or De novo clinically significant hypoxemia (immediate or delayed) with SpO2 < 70% for > 10% of sleep.
Time Frame
90 Days
Other Pre-specified Outcome Measures:
Title
Sleep Testing
Description
Change in Apnea Hypopnea Index from Baseline
Time Frame
90 days, 6-, 12- and 24-months
Title
Epworth Sleepiness Survey (ESS)
Description
Change in ESS from Baseline
Time Frame
90 days, 6-, 12-, 18- and 24-months
Title
Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10)
Description
Change in FOSQ-10 from Baseline
Time Frame
90 days, 6-, 12-, 18- and 24-months
Title
Pain Visual Analog Scale (VAS)
Description
Rate oropharyngeal pain on VAS from 0 to 10; 0 being no pain and 10 is the worst possible pain
Time Frame
Discharge (day 1), 7 days, 30 days, 90 days and every 6 months through 2 years
Title
Eating Assessment Tool (EAT-10)
Description
EAT-10 is a self-administered 10 question symptom survey for dysphagia that a patient rates on a scale of 0-4, with 0=no problem to 4=severe problem.
Time Frame
7 days, 30 days, 90 days and every 6 months through 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Likely suffer moderate to severe OSA based on history and physical or have an established diagnosis of moderate to severe OSA (AHI ≥ 10) based on a prior sleep study. A confirmation baseline sleep study will be performed after enrollment to verify AHI ≥ 10 and ≤ 50, and mixed and central apneas total ≤ 25% of apneas for continued eligibility. Have either failed Positive Airway Pressure (PAP) therapy or decline PAP therapy BMI of 25 - 40 kg/m2 at enrollment Negative result for COVID-19 polymerase chain reaction (RT-PCR) test and absence of clinical symptoms for long COVID-19 relating to deterioration of taste, smell. Exclusion Criteria: Unable or incapable of providing informed written consent Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristine H Selander, M.S.
Phone
17632673202
Email
kselander@cryosa.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stella Rowley, MD
Organizational Affiliation
San Fernando Specialized Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Paitilla Medical Center
City
Panama City
Country
Panama
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leidry Roa
Phone
507-6282-2634
Email
lroa@candmresearch.org
First Name & Middle Initial & Last Name & Degree
Stella Rowley, MD
First Name & Middle Initial & Last Name & Degree
Jolie Crespo, MD
First Name & Middle Initial & Last Name & Degree
Fabio Vega, MD
Facility Name
Punta Pacifica Hospital
City
Panama City
Country
Panama
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leidry Roa
Phone
50762822634
Email
lroa@candmresearch.org
First Name & Middle Initial & Last Name & Degree
Jose Lorenzo

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pilot Study of the CHILLS Cryotherapy System for the Treatment of OSA

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