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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAtriCure, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Subjects who have or will have an amputation procedure.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • cryoablation

    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.

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: Subjects who have or will have an amputation procedure.1 intervention

Trial outcomes

Primary outcomes

1

Primary Outcome Measure

CryoNerve Block procedural complications

Time frame
30 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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