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NEUROCUPLE™ in TKA Patients to Enhance Pain Management
Sponsor: nCap Medical
Summary
This is a randomized (1:1) placebo-controlled clinical trial to determine the feasibility and effectiveness of 30-day application of NEUROCUPLE™ patch for pain reduction and opioid consumption following TKA. Results will establish NEUROCUPLE™ as an effective non-opioid postoperative pain management device for FDA approval. Importantly, we have a placebo device (device without the captor array layer) that looks exactly like the active device, allowing us to conduct a true placebo randomized study.
Official title: Enhancing Pain Management for Knee Replacement Patients Through an Innovative Non-invasive and Opioid-sparing Device (NEUROCUPLE™)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
156
Start Date
2024-09-25
Completion Date
2025-07-18
Last Updated
2026-06-04
Healthy Volunteers
No
Conditions
Interventions
NEUROCUPLE™ Patch
nCAP Medical has developed an effective, safe, non-opioid alternative, the NEUROCUPLE™ device, based on an innovative nanotechnology to reduce surgical pain and facilitate functional recovery while reducing opioid prescriptions, opioid-related adverse events and reducing the cost of care in millions of Americans undergoing TKA each year.
Placebo Patch
The placebo patch is identical to the active patch but with no active agents.
Locations (1)
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, United States