[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586720":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":31,"responsibleParty":51,"collaborators":12,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":12,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":12,"enrollmentInfo":63,"targetDuration":12,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":34,"whyStopped":12,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Northwestern University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","NO_INTERVENTION","The control arm receives eight sessions of a sham (placebo) version of the therapy.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intervention","EXPERIMENTAL","The intervention arm receives eight sessions of Pulsed Acoustic Cellular Expression (PACE) therapy delivered twice weekly for four weeks at level E2",[18],"Device: Pulsed Acoustic Cellular Expression therapy",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","Pulsed Acoustic Cellular Expression therapy","The therapy involves the delivery of targeted acoustic energy that initiates cellular mechanotransduction pathways, inducing beneficial biological responses such as enhanced angiogenesis, modulation of fibroblast proliferation and differentiation, and reorganization of aberrant extracellular matrix components.",[14],[26],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Antoinette Nguyen","CONTACT","312-695-6022","antoinette.nguyen@northwestern.edu",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Lavin Pavilion Suite 2060","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-87.65005,41.85003,{"lat":44,"lon":43},[47,48],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},{"name":49,"role":50,"phone":12,"phoneExt":12,"email":12},"Robert D. Galiano, MD, FACS","PRINCIPAL_INVESTIGATOR",{"type":50,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Robert Galiano","Professor","100586720","shockwave-in-postoperative-breast-reconstruction-fibrosis-100586720",false,"NCT06919042","Shockwave in Postoperative Breast Reconstruction Fibrosis","A Prospective Single-center Study for Evaluation of the Effectiveness of Pulsed Acoustic Cellular Expression Technology on Post-Operative Soft Tissue Fibrosis.","Inclusion Criteria:\n\n* Subjects greater than 18 years of age.\n* Subjects who have undergone plastic surgery procedures and present in the post-operative period with soft tissue firmness suggestive of subcutaneous\u002Fparenchymal fibrosis.\n\nExclusion Criteria:\n\n* Subjects with cardiac pacemakers\n* Other medical or psychiatric condition that may increase the risk associated with study participation, may complicate subject compliance, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.\n* Proximity of fibrotic tissue directly adjacent to bone\n* Face\u002Fneck areas are excluded\n* Patients who, in the opinion of the investigator, would not be compliant with the schedule of study visits","FEMALE","18 Years",{"count":64,"type":65},100,"ESTIMATED","INTERVENTIONAL",[68],"NA","This study evaluates the potential for extracorporeal shockwave therapy to reduce post-operative soft tissue fibrosis.",[71],"Fibrosis Breast",[73,74,75],"breast fibrosis","postoperative fibrosis","shockwave therapy","2026-04-13",{"date":78,"type":79},"2026-04-16","ACTUAL",{"date":81,"type":79},"2024-10-01",{"date":83,"type":65},"2026-09",{"name":5,"class":6},1]