RecruitingNot Applicable

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

United States, Austria, Belgium5,000 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 range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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