Clinical research continues to make strides in managing chronic pain conditions, with a focus on innovative therapies for neuropathic pain like Painful Diabetic Neuropathy (PDN). A new study examines the efficacy and feasibility of BurstDR Spinal Cord Stimulation (SCS) as a promising approach to alleviate pain for individuals suffering from PDN. Sponsored by TriCity Research Center and Abbott, this trial is enrolling participants by invitation only and aims to bring cutting-edge medical device solutions to the forefront.
In this article:
- What changed?
- How could BurstDR SCS impact PDN care?
- What do we know about the research details?
- FAQ
- Conclusion
- Disclaimer
- Announcement Line
What changed?
The study explores BurstDR Spinal Cord Stimulation, an advanced neurostimulation device that aims to deliver pain relief by targeting specific pathways in the spinal cord. The U.S.-based trial is significant because of its focus on PDN, a condition often poorly managed by conventional methods. Key sponsors, such as TriCity Research Center and Abbott, are leveraging their expertise in neuromodulation technology to examine this device’s real-world impact on patient outcomes.
How could BurstDR SCS impact PDN care?
BurstDR SCS operates by delivering electrical stimulation to precise locations in the spinal cord, aligning with regulatory standards for advanced medical devices. The proposed therapy has previously demonstrated reduced side effects and enhanced patient comfort compared to traditional SCS methods. Patients often face persistent pain from PDN, which limits their mobility and quality of life. This device’s ability to modulate pain perception directly could mark a breakthrough in treatment options.
The intended purpose of BurstDR SCS in this context is to mitigate neuropathic pain while ensuring safety and usability for long-term management. The focus is on performance reliability, clinical feasibility, and compliance with safety regulations for high-risk devices.
What do we know about the research details?
The clinical trial is designed to gather robust data on device efficacy, with targeted recruitment methods to ensure participants align with study criteria. Researchers aim to evaluate both qualitative and quantitative metrics, such as pain reduction scores, device tolerability, and potential adverse events. This aligns with high ethical standards outlined in MDR Annex XIV.
With no open public enrollment at this stage, the trial remains tightly controlled to maintain methodological rigor. TriCity Research Center and Abbott have emphasized regulatory compliance throughout, from protocol development to device testing.
FAQ
- What condition is being studied? This study focuses on Painful Diabetic Neuropathy (PDN) and related neuropathic pain.
- What therapy is being used? The intervention involves BurstDR Spinal Cord Stimulation.
- Who sponsors the trial? The study is sponsored by TriCity Research Center and Abbott.
- Can anyone enroll? No, enrollment is by invitation only.
- Where can I find the information? Further details are available on ClinicalTrials.gov.
Conclusion
The BurstDR SCS trial represents an opportunity for patients with PDN to potentially access innovative pain-management technologies. Manufacturing sponsors are leveraging evidence-based design improvements to optimize patient outcomes while adhering to rigorous compliance in medical device development. This commitment to research advances underscores the future of patient-focused healthcare.
Disclaimer
This article is intended for professionals in the clinical, regulatory, and medical device sectors. It is informational only and does not constitute legal or medical advice.
Announcement Line
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07250828?term=medical+device