RecruitingNot Applicable

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

United States5,000 participantsStarted 2018-06-29

Plain-language 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.

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

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

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

What they're measuring

Efficacy of cryo nerve block to generate cryoanalgesia as post operative pain management

Timeframe: From enrollment to 5 years after date of index procedure

Safety of cryo nerve block to generate cryoanalgesia as post operative pain management

Timeframe: From enrollment to 5 years after date of index procedure

Trial details

NCT IDNCT05110989

SponsorAtriCure, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2035-01

Contact for this trial

Elizabeth Menard

8327120715 REDUCE-REGISTRY@atricure.com

View on ClinicalTrials.gov More Post Operative Pain trials