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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

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

NCT ID

NCT05542082

First Posted

September 13, 2022

Last Updated

September 13, 2022

Sponsor

Cryosa, Inc.

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

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

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

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

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

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

lroa@candmresearch.org

First Name & Middle Initial & Last Name & Degree

Jose Lorenzo

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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