NCT07628517

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started May 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
May 2026Apr 2027

First Submitted

Initial submission to the registry

May 6, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

May 18, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

May 6, 2026

Last Update Submit

June 4, 2026

Conditions

MammaplastyBreast Reconstruction

Outcome Measures

Primary Outcomes (1)

  • Extraction from medical records of a copy of MRI and Vectra XT 3D images

    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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2026

First Posted

June 5, 2026

Study Start

May 18, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

June 5, 2026

Record last verified: 2026-06