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

Part of paid clinical trials in Pittsfield, Massachusetts.

Sponsor
AtriCure, Inc.
Study ID
NCT06908538
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

Start date
Apr 1, 2025
Status verified
Mar 2025
Primary completion
Apr 30, 2035
Completion
Apr 30, 2035

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Primary Outcome Measure [ Time Frame: 30 days ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Berkshire Medical CenterPittsfieldMassachusetts01201
Leslie Drager Study Coordinator
[email protected]
207-991-2008
Mark Kryskow (PRINCIPAL_INVESTIGATOR)
Hannah Firth (SUB_INVESTIGATOR)
Elliot HospitalManchesterNew Hampshire03101
Lizabeth O'Connor
[email protected]
603-669-5300
Bryan Houseman (PRINCIPAL_INVESTIGATOR)
Lizabeth O'Connor (SUB_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10017
Thomas Callahan
[email protected]
646-929-7870
Jamie Levine (PRINCIPAL_INVESTIGATOR)
Medical College of Wisconsin/Froedtert HospitalMilwaukeeWisconsin53226
Elizabeth Weseman
[email protected]
414-955-1810
Peter Rossi (PRINCIPAL_INVESTIGATOR)

Find similar trials in Pittsfield, MA

By research site
Berkshire Medical Center· Pittsfield, MAElliot Hospital· Manchester, NHNYU Langone Health· New York, NYMedical College of Wisconsin/Froedtert Hospital· Milwaukee, WI

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