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NEUROCUPLE™ in TKA Patients to Enhance Pain Management

NCT06460350 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2026-02-20

No results posted yet for this study

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.

Conditions

  • Total Knee Arthroplasty

Interventions

DEVICE

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.

DEVICE

Placebo Patch

The placebo patch is identical to the active patch but with no active agents.

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • nCap Medical

    lead INDUSTRY

Principal Investigators

  • Jacques E. Chelly, MD, PhD, MBA · University of Pittsburgh / UPMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-25
Primary Completion
2025-07-18
Completion
2025-07-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06460350 on ClinicalTrials.gov