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

AtriCure

Status: Enrolling

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

Treatments: Device: cryoablation

Study type: Observational

Funder types: Industry

Identifiers

NCT06908538

RP-2025-0001

Details and patient eligibility

About

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

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,000 participants in 1 patient group

Subjects who have or will have an amputation procedure.

Description:

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.

Treatment:

Device: cryoablation