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A Pilot Study Investigating the nCAP Signal Relief Patch in Subjects Undergoing Primary Hip or Knee Replacement Surgery
N/A
Waitlist Available
Led By Jacques E Chelly, MD
Research Sponsored by Jacques E. Chelly
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1-30 post-operative
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a special patch called the nCAP Signal Relief Patch to help reduce pain in patients having hip or knee replacement surgery. The patch is placed on the skin where it hurts and works by blocking pain signals, aiming to reduce the need for opioid painkillers.
Eligible Conditions
- Surgical Pain
- Opioid Use Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening visit
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy of the nCAP Signal Relief Patch in Affecting Perioperative Opioid Requirement
Secondary study objectives
Average Score of Functionality Post-Operative
Average Score of Functionality at Baseline
Change in Post-operative Pain Rating Using the Pain Catastrophizing Scale
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: nCAP + ERASExperimental Treatment2 Interventions
Participants will have the nCAP Signal Relief Patch and complete Enhanced Recovery After Surgery (ERAS) standard of care. After surgery, the subjects randomized to the intervention group will have the nCAP Signal Relief patch applied to their surgical dressing by a trained researcher in the immediate Post Anesthesia Care Unit (PACU).
Group II: ERAS aloneActive Control1 Intervention
Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no nCAP patch.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nCAP Signal Relief Patch
2022
N/A
~80
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Who is running the clinical trial?
Jacques E. ChellyLead Sponsor
9 Previous Clinical Trials
627 Total Patients Enrolled
nCap MedicalIndustry Sponsor
2 Previous Clinical Trials
210 Total Patients Enrolled
Jacques E Chelly, MDPrincipal InvestigatorUniversity of Pittsburgh
5 Previous Clinical Trials
201 Total Patients Enrolled