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Prospective Agreement Study of Magnetic Resonance Imaging Measurements and Intraoperative Dimensions During Gluteal Permanent Synthetic Filler Removal

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 9, 2026 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07808996
Lead Sponsor Research Inc
Conditions
(from sponsor)		 Gluteal Tissue Ischemia Risk, Foreign-Body Reaction, Soft Tissue Filler Complication
Related terms Foreign-Body Reaction
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov