Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain (VANISH)

January 6, 2026 updated by: AtriCure, Inc.

Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain (VANISH)

The goal of this Registry is to see how the device is used when freezing nerves during an amputation procedure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
        • Recruiting
        • Berkshire Medical Center
        • Contact:
          • Leslie Drager Study Coordinator
          • Phone Number: 207-991-2008
          • Email: ldrager@bhs1.org
        • Principal Investigator:
          • Mark Kryskow
        • Sub-Investigator:
          • Hannah Firth
    • New Hampshire
      • Manchester, New Hampshire, United States, 03101
        • Recruiting
        • Elliot Hospital
        • Contact:
        • Principal Investigator:
          • Bryan Houseman
        • Sub-Investigator:
          • Lizabeth O'Connor
    • New York
      • New York, New York, United States, 10017
        • Recruiting
        • NYU Langone Health
        • Contact:
        • Principal Investigator:
          • Jamie Levine
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin/Froedtert Hospital
        • Contact:
        • Principal Investigator:
          • Peter Rossi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects who have or will have an amputation procedure.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects who have or will have an amputation procedure.
The primary objective of this Registry is to capture real-world safety and performance data on AtriCure devices used to cryoablate nerves during an extremity amputation procedure.
Device: cryoablation
Cryoanalgesia, also known as Cryoablation, Cryoneurolysis, or Cryonerve Block, has been used for decades to treat chronic pain and has recently been employed for the management of Phantom Limb Pain. Cryoanalgesia involves the use of a probe to apply extreme cold (approximately -70◦C) to induce reversible axonal injury and Wallerian degeneration to produce a temporary conduction block that is sustained until regeneration of the axon and sensation is restored, typically weeks to months later.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome Measure
Time Frame: 30 days
CryoNerve Block procedural complications
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AtriCure, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

April 1, 2035

Study Completion (Estimated)

April 1, 2035

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 3, 2025

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP-2025-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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