[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607197":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":33,"centralContacts":37,"locations":46,"responsibleParty":73,"collaborators":75,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":23,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":23,"enrollmentInfo":88,"targetDuration":23,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":23,"overallStatus":49,"whyStopped":23,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Inova Health Care Services","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"NeuroCuple device","ACTIVE_COMPARATOR","Device placed by research personnel in PACU prior to transfer to the post-partum unit",[13],"Device: NeuroCuple",{"label":15,"type":16,"description":11,"interventionNames":17},"Sham device","SHAM_COMPARATOR",[18],"Device: Sham",{"label":20,"type":21,"description":22,"interventionNames":23},"Standard of care","NO_INTERVENTION","No device will be placed",null,[25,30],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":23},"DEVICE","NeuroCuple","Device around the abdomen over c-section bandages in the PACU",[9],{"type":26,"name":31,"description":28,"armGroupLabels":32,"otherNames":23},"Sham",[15],[34],{"name":35,"affiliation":5,"role":36},"Antonio Saad, MD","PRINCIPAL_INVESTIGATOR",[38,42],{"name":35,"role":39,"phone":40,"phoneExt":23,"email":41},"CONTACT","7037766040","antonio.saad@inova.org",{"name":43,"role":39,"phone":44,"phoneExt":23,"email":45},"Michelle Cassidy, phD","7037764600","michelle.cassidy@inova.org",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Inova Fairfax Medical Campus","RECRUITING","Falls Church","Virginia","22042","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-77.17109,38.88233,{"lat":59,"lon":58},[62,64,67,68,71],{"name":35,"role":39,"phone":63,"phoneExt":23,"email":41},"703-776-6040",{"name":65,"role":39,"phone":66,"phoneExt":23,"email":45},"Michelle Cassidy, PhD, RN","(703) 776-4600",{"name":35,"role":36,"phone":23,"phoneExt":23,"email":23},{"name":69,"role":70,"phone":23,"phoneExt":23,"email":23},"Maggie Wong, MD","SUB_INVESTIGATOR",{"name":72,"role":70,"phone":23,"phoneExt":23,"email":23},"Elle Murrin, MD",{"type":74,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[76],{"name":77,"class":78},"nCap Medical","INDUSTRY","100607197","impact-of-the-neurocuple-device-on-pain-management-after-cesarean-delivery-100607197",false,"NCT07185425","Impact of the NeuroCuple Device on Pain Management After Cesarean Delivery","Management of Postoperative Pain After Cesarean Delivery Using Non-pharmacological Analgesic Device, NeuroCuple™","Inclusion Criteria:\n\n* Female 18 years or older able to provide informed consent in English or Spanish\n* Scheduled for a planned or unplanned non-emergent cesarean delivery under neuraxial anesthesia\n* Intact skin surfaces around the operative skin incision area at the site of patch application\n* Pfannestiel skin incision\n\nExclusion Criteria:\n\n* Active drug abuse\n* Chronic opioid user\n* Severe chronic pain\n* Psoriasis vulgaris or other skin conditions precluding safe device application\n* 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\n* Subject with reasons to maintain an epidural beyond operative room\n* Subject with complex surgery or subject who may need more than a cesarean surgery with possible tubal sterilization procedure\n* Subject is deemed not suitable for the study at the discretion of the principal Investigator","FEMALE","18 Years",{"count":89,"type":90},180,"ESTIMATED","INTERVENTIONAL",[93],"NA","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 analgesic device for management of postoperative pain. The investigators hypothesize that women treated with the Neurocuple device will experience less pain and consequently require less opioid pain medication after cesarean delivery compared to women who receive standard post-surgical medication.",[96,97,98],"Pain","Analgesia","Pregnancy","2025-10-14",{"date":101,"type":102},"2025-10-16","ACTUAL",{"date":104,"type":102},"2025-10-13",{"date":106,"type":90},"2027-09",{"name":5,"class":6},1]