AmputationVANISHNCT06908538
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
An observational study of Amputation and Amputation of Lower Limb, run by AtriCure, Inc. at 6 sites in United States.
Trial summary
The goal of this Registry is to see how the device is used when freezing nerves during an amputation procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Amputation of Lower Limb, Amputation of Upper Limb
- What is being tested?
- cryoablation
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Apr 2025to Apr 2035
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have or will have an amputation procedure.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Subh Das, 614-366-6596, subhashish.das@osumc.edu
Benjamin Lee
- Recruiting
Prisma Health - Upstate
Greenville, South Carolina, 29605
Kim Byers, 864-346-7916, kim.byers@prismahealth.org
Sagar Gandhi
- Recruiting
Elliot Hospital
Manchester, New Hampshire, 03101
Lizabeth O'Connor, 603-669-5300, Oconnor8@elliot-hs.org
Bryan Houseman
- Recruiting
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, 53226
Elizabeth Weseman, 414-955-1810, eweseman@mcw.edu
Peter Rossi
- Recruiting
NYU Langone Health
New York, New York, 10017
Thomas Callahan, 646-929-7870, Thomas.Calahan@nyulangone.org
Jamie Levine
- Recruiting
Berkshire Medical Center
Pittsfield, Massachusetts, 01201
Leslie Drager Study Coordinator, 207-991-2008, ldrager@bhs1.org
Mark Kryskow
About this study
Official title: Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain (VANISH)
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
- Being tested
- cryoablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryoablationDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
CryoNerve Block procedural complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start1 Apr 2025
- Primary completionApr 2035 (estimated)
- Study completionApr 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- AtriCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908538
- Sponsor's protocol ID
- RP-2025-0001
- Acronym
- VANISH
- Status last verified
- Aug 2026
- First submitted
- 19 Mar 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain (VANISH)
- ClinicalTrials.gov ID
- NCT06908538
- Acronym / sponsor ID
- VANISH / RP-2025-0001
- Conditions
- Amputation, Amputation of Lower Limb, Amputation of Upper Limb, Amputation, Limb Loss, Amputation, Traumatic/Surgery, Cryo Analgesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- AtriCure, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Apr 2035 (estimated)
- Study completion
- Apr 2035 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this Registry is to see how the device is used when freezing nerves during an amputation procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects who have or will have an amputation procedure. | – | Device: cryoablationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have or will have an amputation procedure.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryoablationCryoanalgesia, 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. | Device | Subjects who have or will have an amputation procedure. |
Primary outcome
Primary Outcome Measure
Time frame: 30 days
CryoNerve Block procedural complications
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation and Amputation of Lower Limb, run by AtriCure, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Senior Registry Specialist (1 (866) 349-2342, CryoNB-registry@atricure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.