Post Operative PainREDUCENCT05110989
A Multicenter Patient Registry on Outcomes From Cryoanalgesia of the Intercostal Nerves
An observational study of Post Operative Pain, run by AtriCure, Inc. at 11 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- AtriCure Cryo Nerve Block (cryoNB) Device Family
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 29 Jun 2018to Jan 2040
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The REDUCE registry eligibility is open to sites and physicians performing cryo nerve block procedures as treatments for patients to generate croanalgesia as a post operative pain management method using the AtriCure Cryo Nerve Block (cryoNB) Device Family. Subjects must have been scheduled to undergo or have undergone the cryo nerve block procedure and must meet all eligibility criteria in order for their treatment and results to be considered for this registry.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 5 countries
United States7 sites, 6 recruiting
- Recruiting
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, 21401
David J Caparrelli, MD, 443-481-1358, dcaparrell@luminishealth.org
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
Katherine Gloria, 513-585-1777, Katherineaubre.Glori@thechristhospital.com
Julian Guitron, MD
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Joan Reynoso Rosario, MD, 713-798-6119, joan.reynosorosario@bcm.edu
Gabriel Loor, MD
- Recruiting
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
Brittany Merritt, 904-202-7319, brittany.merritt@bmcjax.com
David Hall
- Completed
St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
- Recruiting
Elliot Hospital
Manchester, New Hampshire, 03101
Curits Quinn, MD
- Recruiting
AdventHealth
Orlando, Florida, 32803
Jessica Injiac, 407-303-4265, Jessica.injiac@adventhealth.com
Colleen Gaughan, MD
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna
Nina Fruhmann, +43(0) 1 40400 56440, nina.fruhmann@meduniwien.ac.at
Clemens Aigner, MD, MBA, FETCS
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven
Céline Rihon, + 32 16 34 12 13, celine.rihon@uzleuven.be
Hans Van Veer, MD, FEBS-OGSurg
Germany1 site, 1 recruiting
- Recruiting
University of Heidelberg
Heidelberg
Stefanie Lo Giudice, +49 6221 396-8110, stefanie.logiudice@med.uni-heidelberg.de
Hauke Winter
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals Leicester NHS Trust
Leicester
Rebecca Boyles, 0116 2583370, rebecca.boyles1@nhs.net
Edward Caruana
About this study
Official title: The CryoICE™ Cryoanalgesia Registry for Pain Management in Post-cardiothoracic Surgery Via Cryoablation of the Intercostal Nerves
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
- Being tested
- AtriCure Cryo Nerve Block (cryoNB) Device Family
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtriCure Cryo Nerve Block (cryoNB) Device FamilyDevice
Use of Atricure Cryo Nerve Block Device Family to generate cryoanalgesia for the management of post operative pain.
What is being measured
The primary outcome is the main question the study is designed to answer.
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 5 years.
Measured: From enrollment to 5 years after date of index procedure
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.
Measured: From enrollment to 5 years after date of index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start29 Jun 2018
- Primary completionJan 2035 (estimated)
- Study completionJan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- AtriCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Curits Quinn, MD, Principal investigator, Elliot Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110989
- Sponsor's protocol ID
- REDUCE2018
- Acronym
- REDUCE
- Status last verified
- Jun 2026
- First submitted
- 28 Oct 2021
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CryoICE™ Cryoanalgesia Registry for Pain Management in Post-cardiothoracic Surgery Via Cryoablation of the Intercostal Nerves
- ClinicalTrials.gov ID
- NCT05110989
- Acronym / sponsor ID
- REDUCE / REDUCE2018
- Conditions
- Post Operative Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- AtriCure, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- Jan 2035 (estimated)
- Study completion
- Jan 2040 (estimated)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The REDUCE registry eligibility is open to sites and physicians performing cryo nerve block procedures as treatments for patients to generate croanalgesia as a post operative pain management method using the AtriCure Cryo Nerve Block (cryoNB) Device Family. Subjects must have been scheduled to undergo or have undergone the cryo nerve block procedure and must meet all eligibility criteria in order for their treatment and results to be considered for this registry.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtriCure Cryo Nerve Block (cryoNB) Device FamilyUse of Atricure Cryo Nerve Block Device Family to generate cryoanalgesia for the management of post operative pain. | Device | – |
Primary outcome
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
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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Curits Quinn, MD principal investigator
Elliot Hospital
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Pain, run by AtriCure, Inc. at 11 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Austria, Belgium, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Menard (8327120715, REDUCE-REGISTRY@atricure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.