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

Recruiting

• Conditions: Post Operative Pain

• Registration Number: NCT05110989
• Lead Sponsor: AtriCure, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-29
• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-11-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-20
• Primary Completion: 2035-01
• Study Completion: 2040-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of cryo nerve block to generate cryoanalgesia as post operative pain management	From enrollment to 5 years after date of index procedure	Collect pain score to assess the effect of cryoanalgesia effect with a follow up duration of up to 5 years.
Safety of cryo nerve block to generate cryoanalgesia as post operative pain management	From enrollment to 5 years after date of index procedure	Collect adverse events occurred during and post operation to assess the safety of the cryo nerve block procedure.

Trial Locations

Locations (6)

AdventHealth; 🇺🇸 Orlando, Florida, United States

Henry Ford Health Rochester Hospital; 🇺🇸 Rochester, Michigan, United States

St. Luke's Hospital of Kansas City; 🇺🇸 Kansas City, Missouri, United States

Elliot Hospital; 🇺🇸 Manchester, New Hampshire, United States

The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States