Custom Breast Implants With 3D Imaging

June 4, 2026 updated by: HELMo Link asbl

Personalized Breast Implant Modeling Using Imaging Techniques (MRI and Vectra)

The aim of this study is to use MRI and Vectra metadata from patients in order to develop the "customizable" aspect of the MyBREAST One implant through computer modeling of this implant based on the collected metadata.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

25

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients from the Plastic and Maxillofacial Surgery Department of CHU Liège.

Description

Inclusion Criteria:

  • The targeted patients will be those undergoing mastectomy following neoadjuvant chemotherapy, prophylactically, or in the context of lobular cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extraction from medical records of a copy of MRI and Vectra XT 3D images
Time Frame: Immediately after the intervention/procedure/surgery
For patient undergoing mastectomy after neoadjuvant chemotherapy, consent to use MRI and Vectra images will be requested during chemotherapy when the Vectra is taken. MRI will be extracted from medical records.
Immediately after the intervention/procedure/surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HELMo Link asbl

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 18, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

June 4, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2026/275

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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