MammaplastyNCT07628517
Custom Breast Implants With 3D Imaging
An observational study of Mammaplasty and Breast Reconstruction, run by HELMo Link asbl.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mammaplasty, Breast Reconstruction
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 18 May 2026to Apr 2027
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients from the Plastic and Maxillofacial Surgery Department of CHU Liège.
Who may be able to join
- The targeted patients will be those undergoing mastectomy following neoadjuvant chemotherapy, prophylactically, or in the context of lobular cancer.
Who cannot join
None listed.
About this study
Official title: 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.
- Conditions
- Mammaplasty, Breast Reconstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start18 May 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MammaplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HELMo Link asbl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628517
- Sponsor's protocol ID
- 2026/275
- Status last verified
- Jun 2026
- First submitted
- 6 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Breast Implant Modeling Using Imaging Techniques (MRI and Vectra)
- ClinicalTrials.gov ID
- NCT07628517
- Acronym / sponsor ID
- 2026/275
- Conditions
- Mammaplasty, Breast Reconstruction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- HELMo Link asblUniversity, hospital or other
- Study start
- 18 May 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the Plastic and Maxillofacial Surgery Department of CHU Liège.
Key inclusion criteria (1 listed)
- The targeted patients will be those undergoing mastectomy following neoadjuvant chemotherapy, prophylactically, or in the context of lobular cancer.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mammaplasty and Breast Reconstruction, run by HELMo Link asbl.
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 1 inclusion and 0 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: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Extraction from medical records of a copy of MRI and Vectra XT 3D images (time frame: Immediately after the intervention/procedure/surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2026.