Actively Recruiting
The CryoICE22 Cryoanalgesia Registry for Pain Management in Post-cardiothoracic Surgery Via Cryoablation of the Intercostal Nerves
Led by AtriCure, Inc. · Updated on 2026-03-24
5000
Participants Needed
11
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter observational patient registry to collect information on outcomes from patients undergoing cryoablation of the intercostal nerves, also known as cryoanalgesia, for managing post-operative pain after cardiothoracic surgery. This registry includes both retrospective and prospective data to better understand the effectiveness and safety of this pain management approach over time. The study involves the use of the AtriCure Cryo Nerve Block Device Family to create cryoanalgesia for post-operative pain control. Patients who have undergone or are scheduled to undergo cryoablation using these devices, or similar patients treated without cryoablation, are included in the registry. The study captures data from the time of enrollment up to five years following the initial procedure. Participants contribute data through their clinical treatment records as part of this registry. The research team monitors the efficacy and safety of the cryo nerve block method for pain management over a five-year period from the date of the index procedure. This long-term follow-up helps researchers understand both the benefits and any risks associated with this treatment. The overall participation duration varies depending on when the patient was treated and enrolled.
CONDITIONS
Brief Title
A Multicenter Patient Registry on Outcomes From Cryoanalgesia of the Intercostal Nerves
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 12 years or older able to provide informed consent or assent according to local laws.
- Patients scheduled to undergo or who have undergone cryoablation of the intercostal nerves using at least one AtriCure device or similar treatment without cryoablation.
You will not qualify if you...
- Patients enrolled in another clinical trial that could affect treatment with the registry devices.
- Patients excluded by local governance requirements.
- Women of childbearing potential who are pregnant or plan to become pregnant during the study period.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From enrollment to the date of the index procedure
Participants undergo cryoablation of the intercostal nerves using the AtriCure Cryo Nerve Block Device for post-operative pain management.
Duration - Up to 5 years after the index procedure
Participants are monitored for safety and efficacy outcomes related to cryoanalgesia for up to 5 years after the index procedure.
Trial Site Locations
Total: 11 locations
1
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
Actively Recruiting
2
AdventHealth
Orlando, Florida, United States, 32803
Actively Recruiting
3
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
Actively Recruiting
4
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Completed
5
Elliot Hospital
Manchester, New Hampshire, United States, 03101
Actively Recruiting
6
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
7
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
8
Medical University of Vienna
Vienna, Austria
Actively Recruiting
9
UZ Leuven
Leuven, Belgium
Actively Recruiting
10
University of Heidelberg
Heidelberg, Germany
Actively Recruiting
11
University Hospitals Leicester NHS Trust
Leicester, United Kingdom
Actively Recruiting
Research Team
E
Elizabeth Menard
L
Laura O'Brien, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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