Tracking nerve-freezing during limb amputation to learn about post-operative and phantom limb pain
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain (VANISH)
This registry will track how freezing nerves (cryoablation) is used during limb amputations to see if it affects post-operative and phantom limb pain in adults who have or will have an amputation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AtriCure, Inc. Industry-sponsored |
| Locations | 4 sites (Pittsfield, Massachusetts and 3 other locations) |
| Trial ID | NCT06908538 on ClinicalTrials.gov |
What this trial studies
This is an observational registry that collects real-world data on the use of cryoablation (freezing nerves) during upper and lower limb amputations at several hospitals. Investigators will record procedural details, pain measurements, complications, and follow-up outcomes related to post-operative and phantom limb pain. Eligible adults who have or will have an amputation and can provide consent will be enrolled and followed according to the registry protocol. Women who are pregnant or any patient unable to give informed consent or adhere to follow-up are excluded.
Who should consider this trial
Good fit: Adults (age 18 or older) who have had or will have an upper or lower limb amputation and are able and willing to give informed consent are ideal candidates.
Not a fit: Patients under 18, women who are pregnant or planning pregnancy, or those unable to consent or adhere to follow-up may not benefit or be eligible for inclusion.
Why it matters
Potential benefit: If successful, the registry could help clinicians understand whether nerve-freezing during amputation reduces post-operative and phantom limb pain and inform future care decisions.
How similar studies have performed: Smaller case series and observational reports have suggested cryoablation can reduce neuroma-related and phantom limb pain in some patients, but randomized high-quality evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who have or will have an amputation procedure; * Patients who are willing and capable of providing informed consent; * Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law. Exclusion Criteria: * Women of childbearing potential who are, or plan to become, pregnant during the time of the study; * Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol.
Where this trial is running
Pittsfield, Massachusetts and 3 other locations
- Berkshire Medical Center — Pittsfield, Massachusetts, United States (Recruiting)
- Elliot Hospital — Manchester, New Hampshire, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
- Medical College of Wisconsin/Froedtert Hospital — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Senior Registry Specialist
- Email: CryoNB-registry@atricure.com
- Phone: 1 (866) 349-2342
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.