Enhancing Pain Management for Knee Replacement Patients Through an Innovative Non-invasive and Opioid-sparing Device (NEUROCUPLE™)
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• \>18 years of age
• Scheduled for elective primary unilateral TKA
• T-score \< 60 on the PROMIS Anxiety measure
Locations
United States
Pennsylvania
UPMC Shadyside Hospital
RECRUITING
Pittsburgh
Contact Information
Primary
Anthony Sutera
tsutera@ncap.com
801-566-4124
Backup
Carly Riedmann, MPH
riedmannca@upmc.edu
412-623-4147
Time Frame
Start Date: 2024-09-25
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 140
Treatments
Experimental: NEUROCUPLE™ Group
This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 2-weeks following their TKA surgery.
Placebo_comparator: Placebo Group
This arm of subjects will receive the placebo (non-active, sham) patch to wear for 2-weeks following their TKA surgery.
Related Therapeutic Areas
Sponsors
Leads: nCap Medical
Collaborators: University of Pittsburgh