Gluteal Tissue Ischemia RiskNCT07808996
Prospective Agreement Study of Magnetic Resonance Imaging Measurements and Intraoperative Dimensions During Gluteal Permanent Synthetic Filler Removal
An observational study of Gluteal Tissue Ischemia Risk and Foreign-Body Reaction, run by Research Inc.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gluteal Tissue Ischemia Risk, Foreign-Body Reaction, Soft Tissue Filler Complication
- What is being tested?
- Preoperative MRI Morphometric Mapping and Standardized Intraoperative and Fresh-Specimen Measurement
- Type of treatment
- Surgery or procedure
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults scheduled for surgical excision of gluteal tissue affected by permanent synthetic fillers after preoperative MRI.
Who may be able to join
- Age 18 years or older.
- Gluteal permanent synthetic filler disease scheduled for elective surgical excision.
- Preoperative MRI performed within 90 days before surgery using the study measurement protocol.
- Planned skin/subcutaneous flap elevation that permits direct thickness measurement at predefined landmarks.
- Written informed consent.
Who cannot join
- Emergency surgery or active uncontrolled infection that prevents standardized preoperative imaging or measurement.
- Prior surgery causing loss of the predefined landmarks or making paired measurement impossible.
- Nondiagnostic MRI or incomplete coverage of the planned operative field.
- Specimen fragmentation that prevents standardized fresh-specimen dimension measurement for the secondary endpoint.
- Inability to complete 30-day wound follow-up.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Being tested
- Preoperative MRI Morphometric Mapping, Standardized Intraoperative and Fresh-Specimen Measurement
- Keywords
- Gluteal Reconstruction, Specimen Measurement, Flap Thickness, Surgical Planning, Magnetic Resonance Imaging, Biopolymers
- Medical subject headings
- Foreign-Body Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative MRI Morphometric MappingDiagnostic test
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.
Standardized Intraoperative and Fresh-Specimen MeasurementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| MRI-to-Surgery Agreement Cohort (Cohort) | Participants undergo preoperative MRI morphometry followed by standardized intraoperative flap and specimen measurements during clinically indicated filler removal. Receives: Diagnostic Test: Preoperative MRI Morphometric Mapping; Procedure: Standardized Intraoperative and Fresh-Specimen Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative MRI within 90 days before surgery and the index surgical procedure. 90 days
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: From surgery through postoperative day 30. 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gluteal Tissue Ischemia RiskStudies of the same condition, open and under way.
- More trials run by Research IncThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edison Osorio, MD, plastic surgery, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808996
- Sponsor's protocol ID
- 008
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: patient consent signed before do not take in account share the information on that way
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Agreement Study of Magnetic Resonance Imaging Measurements and Intraoperative Dimensions During Gluteal Permanent Synthetic Filler Removal
- ClinicalTrials.gov ID
- NCT07808996
- Acronym / sponsor ID
- 008
- Keywords
- Gluteal Reconstruction, Specimen Measurement, Flap Thickness, Surgical Planning, Magnetic Resonance Imaging, Biopolymers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Research IncIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI-to-Surgery Agreement Cohort (Cohort) | – | Diagnostic Test: Preoperative MRI Morphometric Mapping, Procedure: Standardized Intraoperative and Fresh-Specimen MeasurementParticipants undergo preoperative MRI morphometry followed by standardized intraoperative flap and specimen measurements during clinically indicated filler removal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults scheduled for surgical excision of gluteal tissue affected by permanent synthetic fillers after preoperative MRI.
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Gluteal permanent synthetic filler disease scheduled for elective surgical excision.
- Preoperative MRI performed within 90 days before surgery using the study measurement protocol.
- Planned skin/subcutaneous flap elevation that permits direct thickness measurement at predefined landmarks.
- Written informed consent.
Key exclusion criteria (5 listed)
- Emergency surgery or active uncontrolled infection that prevents standardized preoperative imaging or measurement.
- Prior surgery causing loss of the predefined landmarks or making paired measurement impossible.
- Nondiagnostic MRI or incomplete coverage of the planned operative field.
- Specimen fragmentation that prevents standardized fresh-specimen dimension measurement for the secondary endpoint.
- Inability to complete 30-day wound follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative MRI Morphometric MappingThree 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. | Diagnostic test | MRI-to-Surgery Agreement Cohort (Cohort) |
| Standardized Intraoperative and Fresh-Specimen MeasurementBefore 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. | Procedure or surgery | MRI-to-Surgery Agreement Cohort (Cohort) |
Primary outcome
Agreement Between MRI and Intraoperative Residual Flap Thickness
Time frame: Preoperative MRI within 90 days before surgery and the index surgical procedure. 90 days
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.
3 secondary outcomes
Agreement Between MRI and Fresh-Specimen Affected-Tissue Dimensions
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
Time frame: Preoperative MRI and the index surgical procedure. 1 day
Incidence of Ischemic Wound Complications
Time frame: From surgery through postoperative day 30. 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No. patient consent signed before do not take in account share the information on that way
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edison Osorio, MD, plastic surgery principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Gluteal Tissue Ischemia Risk and Foreign-Body Reaction, run by Research Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edison Osorio, MD, Plastic surgeon (+573226140611, info@edisonosorio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between MRI and Intraoperative Residual Flap Thickness (time frame: Preoperative MRI within 90 days before surgery and the index surgical procedure. 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.