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Custom Breast Implants With 3D Imaging

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07628517
Enrollment
25
Registered
2026-06-05
Start date
2026-05-18
Completion date
2027-04-01
Last updated
2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Reconstruction, Mammaplasty

Brief summary

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.

Interventions

None listed

Sponsors

HELMo Link asbl
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Extraction from medical records of a copy of MRI and Vectra XT 3D imagesImmediately after the intervention/procedure/surgeryFor 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026