Amputation, Amputation, Limb Loss, Amputation of Lower Limb, Amputation of Upper Limb, Amputation, Traumatic/Surgery, Cryo Analgesia
Conditions
Brief summary
The goal of this Registry is to see how the device is used when freezing nerves during an amputation procedure.
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.
Sponsors
AtriCure, Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure | 30 days | CryoNerve Block procedural complications |
Countries
United States
Contacts
CONTACTSenior Registry Specialist
Outcome results
None listed