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

NCT06908538 | Recruiting FDA Device

• 1 other identifier: RP-2025-0001
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure

  CryoNerve Block procedural complications

  30 days

Study Arms (1)

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.

Device: cryoablation

Interventions

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.

Subjects who have or will have an amputation procedure.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have or will have an amputation procedure.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AtriCure, Inc.: lead

Study Sites (4)

Berkshire Medical Center

Pittsfield, Massachusetts, 01201, United States

RECRUITING

Elliot Hospital

Manchester, New Hampshire, 03101, United States

RECRUITING

NYU Langone Health

New York, New York, 10017, United States

RECRUITING

Medical College of Wisconsin/Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Interventions

Cryosurgery

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Senior Registry Specialist

CONTACT

1 (866) 349-2342; CryoNB-registry@atricure.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 3, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2035
• Study Completion (Estimated): April 1, 2035
• Last Updated: January 7, 2026

Record last verified: 2025-03

Locations

US (4)