An observational study in Gluteal Tissue Ischemia Risk, Foreign-Body Reaction and Soft Tissue Filler Complication, sponsored by Research Inc. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Research Inc · 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.
Participants will receive standardized preoperative MRI morphometric mapping within 90 days before surgery. Two trained readers will measure the affected tissue block in three axes, estimate its volume, and record residual flap thickness at predefined surface landmarks. During the index filler-removal procedure, the landmarks will be reproduced and measured directly with a calibrated sterile device. The fresh specimen will be oriented, measured, and weighed before fixation. Agreement, bias, and prediction error will be quantified. Clinical follow-up through day 30 will determine whether thinner flaps or larger prediction errors are associated with ischemia-related wound complications.
Research Inc is the lead sponsor of 24 studies on the registry; 22 are open to participants now.
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Adults scheduled for surgical excision of gluteal tissue affected by permanent synthetic fillers after preoperative MRI.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergo preoperative MRI morphometry followed by standardized intraoperative flap and specimen measurements during clinically indicated filler removal.
Diagnostic Test: Preoperative MRI Morphometric Mapping · Procedure: Standardized Intraoperative and Fresh-Specimen Measurement
Three orthogonal dimensions of the affected block and residual flap thickness at fixed surface landmarks will be measured on MRI by two trained readers. Affected-tissue volume will be estimated using segmentation when available and a prespecified geometric approximation otherwise. Linked arm/group(s): MRI-to-Surgery Agreement Cohort.
Before closure, residual flap thickness will be measured with a calibrated sterile device at the same mapped landmarks without compressing the tissue. The fresh excised block will be oriented and measured in three axes before fixation. Specimen weight will also be recorded. Linked arm/group(s): MRI-to-Surgery Agreement Cohort.
Agreement Between MRI and Intraoperative Residual Flap Thickness
Residual skin-subcutaneous flap thickness in millimeters will be measured at predefined mapped landmarks on MRI and directly during surgery. Agreement will be summarized using intraclass correlation, mean bias, 95% limits of agreement, and absolute error.
Time frame: Preoperative MRI within 90 days before surgery and the index surgical procedure. 90 days
Agreement Between MRI and Fresh-Specimen Affected-Tissue Dimensions
Maximum craniocaudal, mediolateral, and anteroposterior dimensions in centimeters will be compared between MRI and the oriented fresh specimen before fixation.
Time frame: Preoperative MRI within 90 days before surgery and immediately after specimen removal during the index operation. 90 days
Absolute Percentage Error in Predicted Affected-Tissue Volume
Absolute difference between MRI-predicted and specimen-derived volume divided by specimen-derived volume and multiplied by 100. Lower values indicate more accurate prediction.
Time frame: Preoperative MRI and the index surgical procedure. 1 day
Incidence of Ischemic Wound Complications
Proportion of participants with clinically documented flap ischemia, partial- or full-thickness tissue necrosis, or wound dehiscence judged to be related to tissue perfusion.
Time frame: From surgery through postoperative day 30. 30 days
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Foreign-Body Reaction