[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"soft-tissue-filler-complication\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:soft-tissue-filler-complication":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,73],{"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":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100655295","randomized-evaluation-of-indocyanine-green-fluorescence-angiography-guided-versus-standard-clinical-perfusion-assessment-during-gluteal-permanent-synthetic-filler-removal-100655295",false,"NCT07808957","Randomized Evaluation of Indocyanine Green Fluorescence Angiography-Guided Versus Standard Clinical Perfusion Assessment During Gluteal Permanent Synthetic Filler Removal","Inclusion Criteria:\n\n* Age 18 to 65 years.\n* Scheduled for elective gluteal permanent synthetic filler removal with flap elevation and primary closure.\n* Expected availability of the study fluorescence imaging system.\n* Ability to provide written informed consent and complete 90-day wound follow-up.\n\nExclusion Criteria:\n\n* Known hypersensitivity to indocyanine green.\n* Pregnancy or breastfeeding.\n* Emergency surgery, uncontrolled sepsis, or hemodynamic instability at the time of randomization.\n* Severe hepatic dysfunction or another condition judged by anesthesia to make indocyanine green inappropriate.\n* Prior enrollment in this trial for a contralateral or repeat operation.\n* Inability to undergo standardized postoperative wound assessment.","ALL","18 Years",{"count":18,"type":19},300,"ESTIMATED","INTERVENTIONAL",[22],"NA","This randomized clinical trial will compare indocyanine green fluorescence angiography-guided assessment with standard clinical assessment of gluteal flap perfusion during removal of permanent synthetic fillers. Participants will be assigned 1:1 to fluorescence-guided or standard management. The primary outcome is the occurrence of flap ischemia, ischemia-related wound dehiscence, or tissue necrosis through postoperative day 30. Dye-related adverse reactions, management changes, wound healing, infection, and reoperation will also be evaluated.",[25,26,27],"Soft Tissue Filler Complication","Surgical Flap Ischemia","Tissue Necrosis",[29,30,31,32,33,27,34],"Indocyanine Green","Fluorescence Angiography","Perfusion Imaging","Gluteal Flap","Wound Dehiscence","Biopolymers","NOT_YET_RECRUITING","2026-09-07",{"date":38,"type":39},"2026-09-09","ACTUAL",{"date":41,"type":19},"2026-10-01",{"date":43,"type":19},"2027-10-01",{"name":45,"class":46},"Research Inc","INDUSTRY",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":54,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100655130","prospective-agreement-study-of-magnetic-resonance-imaging-measurements-and-intraoperative-dimensions-during-gluteal-permanent-synthetic-filler-removal-100655130","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.",{"count":55,"type":19},220,"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.",[60,61,25],"Gluteal Tissue Ischemia Risk","Foreign-Body Reaction",[63,64,65,66,67,34],"Gluteal Reconstruction","Specimen Measurement","Flap Thickness","Surgical Planning","Magnetic Resonance Imaging",{"date":38,"type":39},{"date":41,"type":19},{"date":71,"type":19},"2027-12-01",{"name":45,"class":46},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":79,"targetDuration":81,"studyType":57,"phases":4,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":93,"leadSponsor":95,"locationsCount":4},"100654981","prospective-paired-evaluation-of-conventional-versus-structured-magnetic-resonance-imaging-interpretation-for-preoperative-assessment-of-gluteal-permanent-synthetic-filler-disease-100654981","NCT07808463","Prospective Paired Evaluation of Conventional Versus Structured Magnetic Resonance Imaging Interpretation for Preoperative Assessment of Gluteal Permanent Synthetic Filler Disease","Inclusion Criteria:\n\n* Age 18 years or older.\n* History of gluteal injection with a permanent or unknown nonresorbable filler.\n* Preoperative pelvic\u002Fgluteal MRI performed using the study acquisition protocol.\n* Planned surgical removal, biopsy, or operative exploration within 90 days after MRI.\n* Written informed consent for paired image interpretation and use of operative findings.\n\nExclusion Criteria:\n\n* MRI contraindication or nondiagnostic imaging caused by motion or incomplete anatomic coverage.\n* Prior extensive gluteal filler removal that prevents mapping of the predefined compartments.\n* No operative procedure within 90 days after MRI and therefore no reference-standard assessment.\n* Acute life-threatening infection or emergency surgery that prevents completion of the preoperative reporting sequence.\n* Inability to provide consent.",{"count":80,"type":19},200,"1 Day","This prospective paired diagnostic-impact study will compare conventional qualitative MRI reporting with a new structured anatomic classification in adults undergoing surgery for gluteal permanent synthetic filler disease. The structured report will document material effects across superficial, deep, muscular, regional, lymphatic, and interstitial compartments. Standardized intraoperative mapping will serve as the reference standard. The main outcome is the difference in sensitivity for surgically confirmed compartment involvement",[61,25,84],"Gluteal Permanent Synthetic Filler Disease",[34,86,67,87,88,89],"Permanent Synthetic Fillers","Structured Reporting","Preoperative Planning","Gluteal Region",{"date":91,"type":39},"2026-09-08",{"date":41,"type":19},{"date":94,"type":19},"2026-12-31",{"name":45,"class":46}]