Nerve Freezing for Amputation Pain
(VANISH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a device that freezes nerves during amputation to alleviate post-surgery and phantom limb pain. The goal is to gather data on the method's effectiveness in real-world settings. It seeks individuals who have had, or will soon undergo, an amputation. Participants must be able to provide informed consent. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to significant advancements in pain management.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What prior data suggests that this device is safe for freezing nerves during an amputation procedure?
Research shows that AtriCure devices, used to freeze nerves during amputation, have recently received FDA approval, indicating they meet certain safety standards. These devices temporarily freeze nerves to block pain, potentially reducing post-surgery pain.
Early studies have collected real-world data on the safety and effectiveness of these devices. So far, no serious safety issues have emerged. However, ongoing studies aim to gather more detailed safety information, with researchers closely monitoring patient responses to the treatment.
For those considering participation in a trial with these devices, it is reassuring that they have already passed some safety checks. However, like any medical treatment, there may be risks or side effects, so discussing any concerns with a healthcare provider is important.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a novel approach to managing post-operative and phantom limb pain after amputations. Unlike traditional methods that rely on medications like opioids or nerve blocks, this trial uses a technique called cryoablation, which involves freezing nerves to interrupt pain signals. This method has the potential to provide longer-lasting pain relief with fewer side effects than typical pharmacological treatments. By capturing real-world data on safety and performance, this trial could pave the way for a more effective and sustainable solution to a challenging and often debilitating condition.
What evidence suggests that this device is effective for freezing nerves during an amputation?
Research shows that the AtriCure cryoablation device helps manage pain after amputation by freezing nerves. In this trial, researchers will observe participants who have undergone or will undergo an amputation procedure to assess the device's real-world safety and performance. Studies have found that this method can block pain for several months during recovery. Evidence suggests it may reduce both phantom limb pain and pain in the remaining part of the limb, common after amputation. The FDA has approved the device, indicating its potential effectiveness and safety. Early findings suggest it could significantly improve pain management after surgery.12467
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo cryoablation of nerves during an extremity amputation procedure
Follow-up
Participants are monitored for safety and effectiveness after the procedure
What Are the Treatments Tested in This Trial?
Interventions
- Cryoablation
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AtriCure, Inc.
Lead Sponsor
Citations
1.
ir.atricure.com
ir.atricure.com/news-releases/news-release-details/atricure-announces-launch-cryoxttm-device-post-operative-painAtriCure Announces the Launch of the cryoXT™ Device for ...
Recently cleared under an FDA 510(k), the cryoXT device is designed to temporarily block pain following amputation by ablating peripheral nerves ...
Intraoperative cryo nerve block during lower extremity ...
Seventy percent of patients experience phantom limb pain within the first year of an amputation, and 85% of these patients will experience difficult-to-manage ...
Cryo Nerve Block Therapy - Amputation Overview
The effect can last for several months of the patients' recovery period and may aid in the prevention of residual limb pain and phantom limb pain. cryo nerve ...
Trials with Results - Clinical Evidence
This page contains information about clinical trials that are sponsored by AtriCure, Inc. If you wish to learn more, please visit ClinicalTrials.gov.
5.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/ATRC/pressreleases/35744540/atricures-cryoablation-study-a-new-frontier-in-pain-management/AtriCure's Cryoablation Study: A New Frontier in Pain ...
The study seeks to gather real-world data on the safety and performance of this device, which is significant for improving post-operative and ...
Active Clinical Trials | Atrial Fibrillation Treatment
Objective: To capture real-world data on the outcome of ... data on AtriCure devices used to cryoablate nerves during an extremity amputation procedure.
AtriCure, Inc. 7555 Innovation Way Mason, Ohio 45040 ...
This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device. Specifically, data from this ...
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