Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07705295

RIBOSS-01: Prospective Controlled Clinical Trial to Evaluate the Safety and Effectiveness of Rib Osteotomy With Osteosynthesis Stabilization for Waist Narrowing

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Body Contouring Surgery

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica INO

Bogotá, Bogota D.C., 110121, Colombia

About this study

Secondary Objectives:

  • To quantify hip circumference, change and waist-hip ratio improvement.
  • To compare intraoperative and postoperative pain levels (VAS) up to 1 month.
  • To assess radiological consolidation and plate angulation at 3 and 6 months.
  • To record early and late complications (Clavien-Dindo classification) up to 12 months.
  • To measure time to return to physical activity and overall satisfaction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Satisfaction of body results

    Time frame: 1 day before surgery, 1 day after surgery, 7 days after surgery, 30 days after surgery, 3 months after surgery and 6 months after surgery

    Body-QoL total score (0-100) from baseline to 6 months.

  2. Change in waist circumference (cm)

    Time frame: 1 day before surgery, 1 day after surgery, 7 days after surgery, 30 days after surgery, 3 months after surgery and 6 months after surgery

    Change in waist circumference (cm), reduction of the waist circumference

Secondary outcomes

  1. Safety Endpoint

    Time frame: 1 week before surgery and 6 months after surgery

    spirometry values (FEV1, FVC, FEV1/FVC) from before surgery to 6 months after surgery

Sponsors and collaborators

Lead sponsor

Research Inc

Industry

Registry information

Official study title

Prospective Controlled Clinical Trial to Evaluate the Safety and Effectiveness of Rib Osteotomy With Osteosynthesis Stabilization for Waist Narrowing

Acronym: (RIBOSS)

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.