Registry tracking outcomes of cryoanalgesia for post-operative pain management
The CryoICE™ Cryoanalgesia Registry for Pain Management in Post-cardiothoracic Surgery Via Cryoablation of the Intercostal Nerves
This study is tracking how well a new pain management technique using cryoablation of nerve blocks works for patients after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | AtriCure, Inc. Industry-sponsored |
| Locations | 11 sites (Jacksonville, Florida and 10 other locations) |
| Trial ID | NCT05110989 on ClinicalTrials.gov |
What this trial studies
This multicenter observational registry collects data on patients who have undergone cryoablation of the intercostal nerves to manage post-operative pain. It includes both retrospective and prospective data collection to evaluate the effectiveness and outcomes associated with the AtriCure Cryo Nerve Block device. The study aims to provide insights into the benefits and potential complications of this pain management technique across multiple healthcare facilities.
Who should consider this trial
Good fit: Ideal candidates include patients aged 12 and older who are scheduled for or have undergone cryoablation of the intercostal nerves.
Not a fit: Patients currently enrolled in other trials that may affect their treatment or those with specific exclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of cryoanalgesia's effectiveness in managing post-operative pain, leading to improved patient care.
How similar studies have performed: While this approach is observational, similar studies on nerve block techniques have shown promising outcomes in pain management.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Jacksonville, Florida and 10 other locations
- Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States (Recruiting)
- AdventHealth — Orlando, Florida, United States (Recruiting)
- Luminis Health Anne Arundel Medical Center — Annapolis, Maryland, United States (Recruiting)
- St. Luke's Hospital of Kansas City — Kansas City, Missouri, United States (Completed)
- Elliot Hospital — Manchester, New Hampshire, United States (Recruiting)
- The Christ Hospital — Cincinnati, Ohio, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- Medical University of Vienna — Vienna, Austria (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- University of Heidelberg — Heidelberg, Germany (Recruiting)
- University Hospitals Leicester NHS Trust — Leicester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Curits Quinn, MD — Elliot Hospital
- Study coordinator: Elizabeth Menard
- Email: REDUCE-REGISTRY@atricure.com
- Phone: 8327120715
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.