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NCT07705295
RIBOSS-01: Prospective Controlled Clinical Trial to Evaluate the Safety and Effectiveness of Rib Osteotomy With Osteosynthesis Stabilization for Waist Narrowing
Conditions: Body Contouring Surgery
Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: No
Enrollment: 160
Sponsor: Research Inc
Location: Clinica INO Bogotá Bogota D.C.
Summary
The goal of this observational study is to learn about the long-term effects of RIBOSS intervention and demonstrate non-inferiority of postoperative respiratory function (FEV1, FVC, FEV1/FVC) at 6 months in the RIBOSS group compared with controls, using a non-inferiority margin of ≤0.10 L for FEV1 and FVC, and ≤0.05 for the ratio.
Eligibility Criteria
Inclusion Criteria:
* Candidates for elective waist narrowing through high-definition liposculpture.
* Rib XI-XII projection ≥7 cm (CT-based).
* Baseline spirometry within predicted limits.
* Ability to provide informed consent and complete Body-QoL questionnaire.
Exclusion Criteria:
* Prior thoracic surgery, trauma, or rib agenesis.
* Osteoporosis or bone metabolic disease.
* Chronic pulmonary or systemic disease.
* Coagulopathy or psychiatric disorder limiting adherence.
* Pregnancy or lactation.
* Allergy to titanium implants.
Source: ClinicalTrials.gov (NCT07705295). StuddyBuddy aggregates publicly available trial information.
