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Recruiting NCT05110989

A Multicenter Patient Registry on Outcomes From Cryoanalgesia of the Intercostal Nerves

— Observational Post Operative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AtriCure Cryo Nerve Block (cryoNB) Device Family.
Who it may be relevant to
Registry conditions: Post Operative Pain. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Austria, Belgium, Germany, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The CryoICE™ Cryoanalgesia Registry for Pain Management in Post-cardiothoracic Surgery Via Cryoablation of the Intercostal Nerves

Overview

This is a retrospective and prospective, multicenter, observational patient registry to record outcomes from patients undergoing cryoablation of the intercostal nerves (cryoanalgesia) for post-operative pain management.

Interventions

  • Device AtriCure Cryo Nerve Block (cryoNB) Device Family
    Use of Atricure Cryo Nerve Block Device Family to generate cryoanalgesia for the management of post operative pain.

Primary outcome measures

  • Efficacy of cryo nerve block to generate cryoanalgesia as post operative pain management [Time frame: From enrollment to 5 years after date of index procedure]
  • Safety of cryo nerve block to generate cryoanalgesia as post operative pain management [Time frame: From enrollment to 5 years after date of index procedure]

Eligibility criteria

Inclusion criteria

  • Patients whose age is 12 years or above, and are able to give informed consent/assent specific to state and national law.
  • Patients have been scheduled by physician(s) to undergo or have undergone cryoablation of the intercostal nerves utilizing at least one AtriCure device or are similar patients treated without the use of cryoablation

Exclusion criteria

  • Patient is enrolled in a concurrent trial that may impact the treatment offered by the registry devices.
  • Patient with exclusion criteria required by local governance.
  • Women of childbearing potential who are, or plan to become, pregnant during the time of the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 7 centers
  • Baptist MD Anderson Cancer Center — Jacksonville
  • AdventHealth — Orlando
  • Luminis Health Anne Arundel Medical Center — Annapolis
  • St. Luke's Hospital of Kansas City — Kansas City
  • Elliot Hospital — Manchester
  • The Christ Hospital — Cincinnati
  • Baylor College of Medicine — Houston
Austria · 1 center
  • Medical University of Vienna — Vienna
Belgium · 1 center
  • UZ Leuven — Leuven
Germany · 1 center
  • University of Heidelberg — Heidelberg
United Kingdom · 1 center
  • University Hospitals Leicester NHS Trust — Leicester

Identifiers

NCT: NCT05110989 · REDUCE2018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗