NCT07813234 Prospective Evaluation of Anterior Aesthetic Rib Cage Remodeling With Osteosynthesis for Lower Anterior Thoracic Prominence
| NCT ID | NCT07813234 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Research Inc |
| Condition | Chest Wall Deformity |
| Study Type | OBSERVATIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 160 participants in total. It began in 2025-01-01 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This prospective single-group study will evaluate anterior aesthetic rib cage remodeling with osteosynthesis (ARCO) in adults with anteroinferior rib prominence or deformity. The procedure modifies and stabilizes ribs 6 through 8. Inferior rib cage perimeter, CT findings, spirometry, intraoperative respiratory variables, BODY-Q Chest scores, and complications will be assessed through 12 months. The primary outcomes are one-year perimeter change and major procedure-related complications.
Eligibility Criteria
Inclusion Criteria: * Age 18 to 45 years, or older participants with documented acceptable bone health under the final protocol. * Prominence, dysmorphia, or contour concern involving the anteroinferior rib cage and judged appropriate for ARCO. * Preoperative chest CT, spirometry, medical history, and physical examination completed. * BMI 30 kg/m2 or lower. * Ability to comply with CT, spirometry, BODY-Q, and clinical follow-up through 12 months. * Written informed consent Exclusion Criteria: * Osteoarticular disease affecting rib integrity or clinically relevant osteoporosis risk. * Previous major chest surgery or significant thoracic trauma. * Coagulation disorder, chronic pulmonary disease, or uncontrolled systemic disease. * Active cancer, short life expectancy, or contraindication to elective surgery. * Known adverse reaction to the proposed osteosynthesis material. * Psychiatric condition or body-image disorder that, after specialist assessment when indicated, impairs informed decision-making or realistic expectations. * Pregnancy or breastfeeding.
Contact & Investigator
Hugo Aguilar, MD, plastic surgery
PRINCIPAL INVESTIGATOR
Frequently Asked Questions
Who can join the NCT07813234 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chest Wall Deformity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07813234 currently recruiting?
Yes, NCT07813234 is actively recruiting participants. Contact the research team at havplasticacademy@gmail.com for enrollment information.
Where is the NCT07813234 trial being conducted?
This trial is being conducted at Bogotá, Colombia.
Who is sponsoring the NCT07813234 clinical trial?
NCT07813234 is sponsored by Research Inc. The principal investigator is Hugo Aguilar, MD, plastic surgery. The trial plans to enroll 160 participants.