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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-01

Study Completion Date

2035-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Amputation Amputation of Lower Limb Amputation of Upper Limb Amputation, Limb Loss Amputation, Traumatic/Surgery Cryo Analgesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

cryoablation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No