Custom Breast Implants With 3D Imaging

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.

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Key information

Conditions

Mammaplasty Breast Reconstruction

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

HELMo Link asbl

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Jun 5, 2026
Registry last updated: Jun 5, 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.

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

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