Actively Recruiting

Age: 12Years +
All Genders
ID05110989

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

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

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.

Long-term Monitoring

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

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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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