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

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.

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain
• Intervention / Treatment: Device: AtriCure Cryo Nerve Block (cryoNB) Device Family

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Elizabeth Menard; Phone Number: 8327120715; Email: REDUCE-REGISTRY@atricure.com
• Study Contact Backup: Name: Laura O'Brien, PhD; Phone Number: 763-310-6151; Email: lobrien@atricure.com

Study Locations

• Austria
  • Vienna, Austria
    • Recruiting
    • Medical University of Vienna
    • Contact: Nina Fruhmann; Phone Number: +43(0) 1 40400 56440; Email: nina.fruhmann@meduniwien.ac.at
    • Principal Investigator: Clemens Aigner, MD, MBA, FETCS
• Belgium
  • Leuven, Belgium
    • Recruiting
    • UZ Leuven
    • Contact: Céline Rihon; Phone Number: + 32 16 34 12 13; Email: celine.rihon@uzleuven.be
    • Principal Investigator: Hans Van Veer, MD, FEBS-OGSurg
• Germany
  • Heidelberg, Germany
    • Recruiting
    • University of Heidelberg
    • Contact: Stefanie Lo Giudice; Phone Number: +49 6221 396-8110; Email: stefanie.logiudice@med.uni-heidelberg.de
    • Principal Investigator: Hauke Winter
• United Kingdom
  • Leicester, United Kingdom
    • Recruiting
    • University Hospitals Leicester NHS Trust
    • Contact: Rebecca Boyles; Phone Number: 0116 2583370; Email: rebecca.boyles1@nhs.net
    • Principal Investigator: Edward Caruana
• United States
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Recruiting
      • Baptist MD Anderson Cancer Center
      • Contact: Brittany Merritt; Phone Number: 904-202-7319; Email: brittany.merritt@bmcjax.com
      • Principal Investigator: David Hall
    • Orlando, Florida, United States, 32803
      • Recruiting
      • Adventhealth
      • Contact: Jessica Injiac; Phone Number: 407-303-4265; Email: Jessica.injiac@adventhealth.com
      • Principal Investigator: Colleen Gaughan, MD
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Recruiting
      • Luminis Health Anne Arundel Medical Center
      • Contact: David J Caparrelli, MD; Phone Number: 443-481-1358; Email: dcaparrell@luminishealth.org
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Completed
      • St. Luke's Hospital of Kansas City
  • New Hampshire
    • Manchester, New Hampshire, United States, 03101
      • Recruiting
      • Elliot Hospital
      • Contact: Curits Quinn, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • The Christ Hospital
      • Contact: Katherine Gloria; Phone Number: 513-585-1777; Email: Katherineaubre.Glori@thechristhospital.com
      • Principal Investigator: Julian Guitron, MD
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
      • Contact: Joan Reynoso Rosario, MD; Phone Number: 713-798-6119; Email: joan.reynosorosario@bcm.edu
      • Principal Investigator: Gabriel Loor, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Patients whose age is 12 years or above, and are able to give informed consent/assent specific to state and national law.
2. 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:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: AtriCure, Inc.
• Investigators: Principal Investigator: Curits Quinn, MD, Elliot Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2018
• Primary Completion (Estimated): January 1, 2035
• Study Completion (Estimated): January 1, 2040

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: REDUCE2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes