Status:
RECRUITING
Impact of the NeuroCuple Device on Pain Management After Cesarean Delivery
Lead Sponsor:
Inova Health Care Services
Collaborating Sponsors:
nCap Medical
Conditions:
Pain
Analgesia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This will be a single-center, sham-controlled, 3 arms, randomized (1:1:1) prospective study in females undergoing cesarean delivery to investigate the impact of NeuroCuple™ non-pharmacological analges...
Detailed Description
This is a single-center, sham-controlled, 3-arms, randomized, prospective study in 180 women undergoing cesarean delivery, with an expected subject enrollment duration of one year. Subjects will be sc...
Eligibility Criteria
Inclusion
- Female 18 years or older able to provide informed consent in English or Spanish
- Scheduled for a planned or unplanned non-emergent cesarean delivery under neuraxial anesthesia
- Intact skin surfaces around the operative skin incision area at the site of patch application
- Pfannestiel skin incision
Exclusion
- Active drug abuse
- Chronic opioid user
- Severe chronic pain
- Psoriasis vulgaris or other skin conditions precluding safe device application
- Subject is concurrently participating in another research study with an investigational drug or medical device that in the Investigator's opinion could impact subject safety or study results
- Subject with reasons to maintain an epidural beyond operative room
- Subject with complex surgery or subject who may need more than a cesarean surgery with possible tubal sterilization procedure
- Subject is deemed not suitable for the study at the discretion of the principal Investigator
Key Trial Info
Start Date :
October 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT07185425
Start Date
October 13 2025
End Date
September 1 2027
Last Update
October 16 2025
Active Locations (1)
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1
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042