[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gluteal-tissue-ischemia-risk\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gluteal-tissue-ischemia-risk":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100655130","prospective-agreement-study-of-magnetic-resonance-imaging-measurements-and-intraoperative-dimensions-during-gluteal-permanent-synthetic-filler-removal-100655130",false,"NCT07808996","Prospective Agreement Study of Magnetic Resonance Imaging Measurements and Intraoperative Dimensions During Gluteal Permanent Synthetic Filler Removal","Inclusion Criteria:\n\n* Age 18 years or older.\n* Gluteal permanent synthetic filler disease scheduled for elective surgical excision.\n* Preoperative MRI performed within 90 days before surgery using the study measurement protocol.\n* Planned skin\u002Fsubcutaneous flap elevation that permits direct thickness measurement at predefined landmarks.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Emergency surgery or active uncontrolled infection that prevents standardized preoperative imaging or measurement.\n* Prior surgery causing loss of the predefined landmarks or making paired measurement impossible.\n* Nondiagnostic MRI or incomplete coverage of the planned operative field.\n* Specimen fragmentation that prevents standardized fresh-specimen dimension measurement for the secondary endpoint.\n* Inability to complete 30-day wound follow-up.","ALL","18 Years",{"count":18,"type":19},220,"ESTIMATED","1 Year","OBSERVATIONAL","This prospective agreement study will compare preoperative MRI measurements with direct surgical measurements in adults undergoing removal of gluteal tissue affected by permanent synthetic fillers. MRI will estimate affected-tissue dimensions and residual skin-flap thickness at predefined landmarks. During surgery, the same flap landmarks and the fresh excised specimen will be measured. The primary outcome is agreement between MRI and intraoperative flap thickness; postoperative ischemia, wound dehiscence, and necrosis will be followed through 30 days.",[24,25,26],"Gluteal Tissue Ischemia Risk","Foreign-Body Reaction","Soft Tissue Filler Complication",[28,29,30,31,32,33],"Gluteal Reconstruction","Specimen Measurement","Flap Thickness","Surgical Planning","Magnetic Resonance Imaging","Biopolymers","NOT_YET_RECRUITING","2026-09-07",{"date":37,"type":38},"2026-09-09","ACTUAL",{"date":40,"type":19},"2026-10-01",{"date":42,"type":19},"2027-12-01",{"name":44,"class":45},"Research Inc","INDUSTRY"]