AzTrials
AzTrials

Body Contouring Surgery(RIBOSS)NCT07705295

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

An observational study of Body Contouring Surgery, run by Research Inc at 1 site in Colombia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Body Contouring Surgery
How many people
160 participants
Where
1 siteColombia
Study dates
20 Feb 2026to 20 Feb 2027
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: The study population will consist of adult male and female patients aged 18 to 45 years seeking elective waist narrowing through high-definition liposculpture at participating center in Bogotá, Colombia. Eligible participants must have a body mass index (BMI) ≤30 kg/m² and demonstrate prominent projection of floating ribs (ribs XI-XII) ≥7 cm on preoperative computed tomography (CT), making them anatomically suitable candidates for structural waist modification. All participants must present with normal baseline spirometry values (FEV1, FVC, and FEV1/FVC within predicted limits) to ensure adequate pulmonary reserve prior to intervention. Participants must be medically fit for elective surgery under general anesthesia and capable of providing written informed consent and completing patient-reported outcome measures, including the Body-QoL questionnaire. Exclusion criteria include prior thoracic surgery or trauma, rib agenesis, osteoporosis or metabolic bone disease, c

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Colombia1 site

  • Clinica INO

    Bogotá, Bogota D.C., 110121

Other trials in Colombia

About this study

Official title: 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.

Read the detailed description

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.
Keywords
rib remodelation surgery, hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07705295
Study groupRoleWhat they receive
RIBOSS Arm (Intervention)Rib Osteotomy with Osteosynthesis Stabilization (RIBOSS) plus liposculpture Procedure: 2-3 cm incision 7 cm lateral to the midline over ribs XI-XII. Periosteal elevation and monocortical osteotomy using piezotome (Cube, Finapolline, France). Controlled greenstick fracture, preserving pleura and neurovascular bundle. Internal fixation with pre-bent 1.5-mm titanium plates (MatrixRIB, Synthes) using 5-hole segments and 6-8 mm screws (two medial, two distal). Mean angulation: 45° (ribs X-XI), 55° (rib XII). Layered closure with absorbable sutures. No corset required postoperatively.
Control ArmStandard liposculpture (VASER and/or MicroAire-assisted) without rib osteosynthesis.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Satisfaction of body results

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

    Measured: 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

  2. Change in waist circumference (cm)

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

    Measured: 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

Secondary outcomes (1)

  1. Safety Endpoint

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

    Measured: 1 week before surgery and 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study start20 Feb 2026
  3. Primary completion20 Aug 2026 (estimated)
  4. Study completion20 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
160 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07705295
Sponsor's protocol ID
002
Acronym
(RIBOSS)
Status last verified
Jul 2026
First submitted
21 Feb 2026
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: It only be able if it is required by someone

Publications

  • Ferreira LM, Bonin GS, Bernardes ABS, Dos Anjos GF, Tariki JY, Boechat C, Cunha MS, Cosac OM, Ferreira PEN, Aloe RC, Ikuta Y, Correa WEM, Felix GAA, Isoldi FC. Is There Scientific Evidence on the Practice of Rib Resection or Remodeling for Body Contouring Purposes?-A Systematic Review. Aesthetic Plast Surg. 2025 Apr;49(7):2007-2014. doi: 10.1007/s00266-025-04685-3. Epub 2025 Jan 21.

    PubMed 39838130

  • Onate Valdivieso C, Onate Valdivieso D, Hoyos AE, Perez Pachon ME, Aguilar Villa H, Michels PJA, Viera A, Benavides JE, Villabona SJ, Ramirez B. Ultrasonic- and Ultrasound-assisted Improvement of Silhouette of the Torso: Bone Structure High-definition Remodeling (Part I). Plast Reconstr Surg Glob Open. 2024 Jan 10;12(1):e5513. doi: 10.1097/GOX.0000000000005513. eCollection 2024 Jan.

    PubMed 38204869

  • Chiu YH, Chiu YJ, Lee CC, Wang TH, Lee JL. Ant Waist Surgery: Aesthetic Removal of Floating Ribs to Decrease the Waist-hip Ratio. Plast Reconstr Surg Glob Open. 2023 Mar 6;11(3):e4852. doi: 10.1097/GOX.0000000000004852. eCollection 2023 Mar.

    PubMed 36891563

  • Aguilar Villa H, Villabona-Florez SJ, Hoyos AE, Perez Pachon ME, Serrano-Reyes HM, Diaz Sandoval CJ. Aesthetic Rib Cage Remodeling with Osteosynthesis: Body Structural High-Definition Reshaping (Rib Osteotomy with Osteosynthesis Stabilization). Plast Reconstr Surg. 2025 Feb 1;155(2):279-288. doi: 10.1097/PRS.0000000000011512. Epub 2024 May 6.

    PubMed 38710099

  • Hoyos AE, Perez Pachon ME, Duarte P, Aguilar Villa H, Proto R, Borras-Osorio M, Castiblanco MP, Leon-Machicado M. Waistline Aesthetic Slimming by Puncture and Parallel Approach for Rib Remodeling Procedures. Aesthet Surg J Open Forum. 2025 May 27;7:ojaf044. doi: 10.1093/asjof/ojaf044. eCollection 2025.

    PubMed 40874070

  • Kudzaev KU, Kraiushkin IA. Waist Narrowing without Removal of Ribs. Plast Reconstr Surg Glob Open. 2021 Jul 12;9(7):e3680. doi: 10.1097/GOX.0000000000003680. eCollection 2021 Jul.

    PubMed 34262840

Questions about this trial

What is this clinical trial studying?

An observational study of Body Contouring Surgery, run by Research Inc at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07705295, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in