Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Cryosa, Inc.
Study ID
NCT06008626
Status
Recruiting
Apply to this trial

Conditions

  • Obstructive Sleep Apnea of Adult

Eligibility Criteria

Sex
ALL
Age
22 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Cryosa Procedure — DEVICE
    Cryotherapy

Study Details

This is a prospective, multicenter, non-randomized single-arm safety and performance study to collect data to evaluate the safety of the Cryosa procedure to treat obstructive sleep apnea (OSA) in patients with moderate to severe OSA. The study will also evaluate the chronic performance of the Cryosa system and collect clinical measures for therapy effectiveness that will be used to demonstrate safety and effectiveness in the next clinical study.

Key Dates

Start date
Sep 12, 2023
Status verified
Apr 2026
Primary completion
Dec 30, 2026
Completion
Jun 30, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cryosa Procedure
    The purpose of this study is to evaluate the safety and effectiveness of Cryosa System applied to the tongue and soft palate in patients with clinically diagnosed obstructive sleep apnea (OSA).

Primary Outcome Measure

Incidence of Serious Procedure or Device/ Treatment Related Events [ Time Frame: First 90 days post-procedure ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
UCHealth University of ColoradoAuroraColorado80045
Yosr Doghri
[email protected]
303-724-6550
Katherine Green, MD (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33136
Kennedy Williams
[email protected]
305-243-2815
Maria Suurna, MD (PRINCIPAL_INVESTIGATOR)
Rush University Medical CenterChicagoIllinois60612
Mahendra Shah, MD, CCRP
[email protected]
312-942-9967
Michael J Hutz, MD (PRINCIPAL_INVESTIGATOR)
Ochsner Baptist Medical CenterNew OrleansLouisiana70115
Shahriar Motazedian, MS
[email protected]
504-703-9860
Joshua Kay, MD (PRINCIPAL_INVESTIGATOR)
Albany ENT & Allergy ServicesAlbanyNew York12205
Julie Baum, LPN
[email protected]
501-701-2085
Gavin Setzen, MD (PRINCIPAL_INVESTIGATOR)
Siobhan Kuhar, MD (SUB_INVESTIGATOR)
Nora Perkins, MD (SUB_INVESTIGATOR)
Specialty Physician AssociatesBethlehemPennsylvania18017-
University of PennsylvaniaPhiladelphiaPennsylvania19104
Everett Seay, B.S.,RPSGT
[email protected]
215-615-8777
Raj Dedhia, MD (PRINCIPAL_INVESTIGATOR)
University of Tennessee Health Sciences CenterMemphisTennessee38163
Linda Sarinoglu
[email protected]
901-426-2480
Carey B Wood, MD (PRINCIPAL_INVESTIGATOR)
Houston Methodist HospitalHoustonTexas77030
Stephanie Camey
[email protected]
832-706-8834
Mas Takashima, MD, FACS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
UCHealth University of Colorado· Aurora, COUniversity of Miami· Miami, FLRush University Medical Center· Chicago, ILOchsner Baptist Medical Center· New Orleans, LAAlbany ENT & Allergy Services· Albany, NYSpecialty Physician Associates· Bethlehem, PA

Related Studies