Recruiting

Observational Study

Sponsor:

AtriCure, Inc.

Code:

NCT06908538

Conditions

Amputation

Amputation of Lower Limb

Amputation of Upper Limb

Amputation, Limb Loss

Amputation, Traumatic/Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

cryoablation

Study Details

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

Study ID

NCT06908538

Start date

Apr 1, 2025

Status verified date

Aug, 2026

Completion date

Apr, 2035

Anticipated

Primary completion date

Apr, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Primary Outcome Measure [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Senior Registry Specialist

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

Locations

Berkshire Medical Center

Recruiting

Pittsfield, Massachusetts, United States, 01201

Contacts

Leslie Drager Study Coordinator

207-991-2008ldrager@bhs1.org

Principal Investigator:

Mark Kryskow

Elliot Hospital

Recruiting

Manchester, New Hampshire, United States, 03101

Contacts

Lizabeth O'Connor

603-669-5300Oconnor8@elliot-hs.org

Principal Investigator:

Bryan Houseman

NYU Langone Health

Recruiting

New York, New York, United States, 10017

Contacts

Thomas Callahan

646-929-7870Thomas.Calahan@nyulangone.org

Principal Investigator:

Jamie Levine

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Subh Das

614-366-6596subhashish.das@osumc.edu

Principal Investigator:

Benjamin Lee

Prisma Health - Upstate

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Kim Byers

864-346-7916kim.byers@prismahealth.org

Principal Investigator:

Sagar Gandhi

Medical College of Wisconsin/Froedtert Hospital

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Elizabeth Weseman

414-955-1810eweseman@mcw.edu

Principal Investigator:

Peter Rossi

More Information

Sponsor

AtriCure, Inc.

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-06. This information was provided to ClinicalTrials.gov by AtriCure, Inc. on 2026-08-26.