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

Post Operative Pain Clinical Trial

— REDUCE  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05110989
• Other study ID #: REDUCE2018
• Status: Enrolling by invitation
• Start date: June 29, 2018
• Est. completion date: January 2027

Study information

• Verified date: February 2023
• Source: AtriCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

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.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Elliot Hospital	Manchester	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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