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 national 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: Enrolling by invitation
• Conditions: Post Operative Pain
• Intervention / Treatment: Device: AtriCure Cryo Nerve Block (cryoNB) Device Family

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Manchester, New Hampshire, United States, 03101
      • Elliot Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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:

• Patient scheduled to undergo or have undergone cryo nerve block procedure as post operative pain management
• Patient >= 18 years of age
• Patient willing to provide written informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this Registry) or authorization per institution and geographical requirements

Exclusion Criteria:

• Patient is enrolled in a concurrent study that may interfere with the outcome of the registry
• Patient with exclusion criteria required by FDA or local governance

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 1 year.	12 months
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.	12 months

Collaborators and Investigators

• Sponsor: AtriCure, Inc.
• Investigators: Principal Investigator: Christopher Towe, MD, University Hospitals Cleveland Medical Center; Principal Investigator: Curits Quinn, MD, Elliot Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 29, 2018
• Primary Completion (ANTICIPATED): January 1, 2027
• Study Completion (ANTICIPATED): January 1, 2027

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): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

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

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