RecruitingNCT06908538

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

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


Sponsor

AtriCure, Inc.

Enrollment

2,000 participants

Start Date

Apr 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria2

  • 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.

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Interventions

DEVICEcryoablation

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.


Locations(4)

Berkshire Medical Center

Pittsfield, Massachusetts, United States

Elliot Hospital

Manchester, New Hampshire, United States

NYU Langone Health

New York, New York, United States

Medical College of Wisconsin/Froedtert Hospital

Milwaukee, Wisconsin, United States

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NCT06908538


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