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RIBOSS-01: Prospective Controlled Clinical Trial to Evaluate the Safety and Effectiveness of Rib Osteotomy With Osteosynthesis Stabilization for Waist Narrowing
Sponsor: Research Inc
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.
Official title: Prospective Controlled Clinical Trial to Evaluate the Safety and Effectiveness of Rib Osteotomy With Osteosynthesis Stabilization for Waist Narrowing
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
OBSERVATIONAL
Enrollment
160
Start Date
2026-02-20
Completion Date
2027-02-20
Last Updated
2026-07-15
Healthy Volunteers
No
Conditions
Locations (1)
Clinica INO
Bogotá, Bogota D.C., Colombia