RIBOSS-01: Prospective Controlled Clinical Trial to Evaluate the Safety and Effectiveness of Rib Osteotomy With Osteosynthesis Stabilization for Waist Narrowing
NCT07705295 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 160
Last updated 2026-07-15
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.
Conditions
- Body Contouring Surgery
Sponsors & Collaborators
-
Research Inc
lead INDUSTRY
Principal Investigators
-
Hugo Aguilar, MD, plastic surgery · HAV Academy
-
Brian Ramirez, MD, Aerospace medicine, MSc, P · Research Inc
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-20
- Primary Completion
- 2026-08-20
- Completion
- 2027-02-20
Countries
- Colombia
Study Locations
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