A Multicenter Patient Registry on Outcomes From Cryoanalgesia of the Intercostal Nerves
REDUCE
The CryoICE™ Cryoanalgesia Registry for Pain Management in Post-cardiothoracic Surgery Via Cryoablation of the Intercostal Nerves
1 other identifier
observational
5,000
5 countries
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2018
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 29, 2018
CompletedFirst Submitted
Initial submission to the registry
October 28, 2021
CompletedFirst Posted
Study publicly available on registry
November 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2040
March 24, 2026
March 1, 2025
16.5 years
October 28, 2021
March 20, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Efficacy of cryo nerve block to generate cryoanalgesia as post operative pain management
Collect pain score to assess the effect of cryoanalgesia effect with a follow up duration of up to 5 years.
From enrollment to 5 years after date of index procedure
Safety of cryo nerve block to generate cryoanalgesia as post operative pain management
Collect adverse events occurred during and post operation to assess the safety of the cryo nerve block procedure.
From enrollment to 5 years after date of index procedure
Interventions
Use of Atricure Cryo Nerve Block Device Family to generate cryoanalgesia for the management of post operative pain.
Eligibility Criteria
The REDUCE registry eligibility is open to sites and physicians performing cryo nerve block procedures as treatments for patients to generate croanalgesia as a post operative pain management method using the AtriCure Cryo Nerve Block (cryoNB) Device Family. Subjects must have been scheduled to undergo or have undergone the cryo nerve block procedure and must meet all eligibility criteria in order for their treatment and results to be considered for this registry.
You may qualify if:
- 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
You may not qualify if:
- Patient is enrolled in a concurrent trial that may impact the treatment offered by the registry devices.
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AtriCure, Inc.lead
Study Sites (11)
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
AdventHealth
Orlando, Florida, 32803, United States
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Elliot Hospital
Manchester, New Hampshire, 03101, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Medical University of Vienna
Vienna, Austria
UZ Leuven
Leuven, Belgium
University of Heidelberg
Heidelberg, Germany
University Hospitals Leicester NHS Trust
Leicester, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Curits Quinn, MD
Elliot Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2021
First Posted
November 8, 2021
Study Start
June 29, 2018
Primary Completion (Estimated)
January 1, 2035
Study Completion (Estimated)
January 1, 2040
Last Updated
March 24, 2026
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share