Recruiting

Cryoanalgesia

Sponsor:

AtriCure, Inc.

Code:

NCT05110989

Conditions

Post Operative Pain

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

AtriCure Cryo Nerve Block (cryoNB) Device Family

Study Details

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.

Conditions

Post Operative Pain

Study ID

NCT05110989

Start date

Jun 29, 2018

Status verified date

Jun, 2026

Completion date

Jan, 2040

Anticipated

Primary completion date

Jan, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Efficacy of cryo nerve block to generate cryoanalgesia as post operative pain management [ Time Frame: From enrollment to 5 years after date of index procedure ]
  • Safety of cryo nerve block to generate cryoanalgesia as post operative pain management [ Time Frame: From enrollment to 5 years after date of index procedure ]

Central Contacts and Locations

Central contacts

Locations

Baptist MD Anderson Cancer Center

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Principal Investigator:

David Hall

AdventHealth

Recruiting

Orlando, Florida, United States, 32803

Contacts

Principal Investigator:

Colleen Gaughan, MD

Luminis Health Anne Arundel Medical Center

Recruiting

Annapolis, Maryland, United States, 21401

Contacts

Elliot Hospital

Recruiting

Manchester, New Hampshire, United States, 03101

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Principal Investigator:

Julian Guitron, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Gabriel Loor, MD

More Information

Sponsor

AtriCure, Inc.

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AtriCure, Inc. on 2026-06-29.