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nCAP Signal Relief Patch for Opioid Use Disorder
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
>18 years of age
Scheduled for elective primary unilateral hip or knee replacement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, 2, 3, 7, 14, and 30 post-operative
Awards & highlights
Study Summary
This trial is testing whether a topical patch can reduce the amount of opioids needed for pain relief after surgery.
Eligible Conditions
- Opioid Use Disorder
- Postoperative Pain
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, 2, 3, 7, 14, and 30 post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, 2, 3, 7, 14, and 30 post-operative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of the nCAP Signal Relief Patch in affecting perioperative opioid requirement
Secondary outcome measures
Change in post-operative pain rating using the Pain Catastrophizing Scale
Change in post-operative pain using a numerical rating scale
Length of hospital stay
+10 moreTrial 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
~70
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Who is running the clinical trial?
Jacques E. ChellyLead Sponsor
8 Previous Clinical Trials
567 Total Patients Enrolled
nCap MedicalIndustry Sponsor
1 Previous Clinical Trials
70 Total Patients Enrolled
Jacques E Chelly, MDPrincipal InvestigatorUniversity of Pittsburgh
5 Previous Clinical Trials
201 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants comprise this research study?
"Affirmative. According to information available on the clinicaltrials.gov website, this medical study is actively recruiting; it first went up on 21 March 2022 and was most recently updated 10 May 2022. Sixty patients will partake in the trial from one site."
Answered by AI
Are there any opportunities to participate in this research endeavor at the present time?
"Affirmative. The data accessible through clinicaltrials.gov verify that this medical investigation, which was first posted on March 21st 2022, is presently recruiting patients. Approximately 60 individuals need to be recruited from 1 site."
Answered by AI
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