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Fat grafting before implant may improve breast reconstruction after mastectomy

NCT ID NCT04343820

Disease control Sponsor: Institut Cancerologie de l'Ouest Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a breast reconstruction method for women who had a mastectomy, with or without radiation. Surgeons first used fat grafting to prepare the chest wall, then placed a breast implant just under the skin (not under the muscle) to reduce pain and animation. The study followed 60 women for 12 months to check for complications and evaluate how the breast looked and felt.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
breast reconstruction procedure (prepectoral implant with lipo-preparation)
What this could lead to
If successful, this approach could offer women a less painful breast reconstruction option with better aesthetic results and fewer complications after mastectomy.
What could go wrong
This is a small, completed feasibility study with 60 participants, so results may not apply to all patients. Complications like infection, implant removal, or poor cosmetic outcome are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

60 people

The number who actually took part.

Started

Dec 2019

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study concerns women who have had a mastectomy and want a secondary breast reconstruction by implant.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Woman aged over 18 * Medical history of mastectomy +/- radiotherapy * Woman requesting breast reconstruction by implant * Patient treated for non-metastatic cancer Exclusion Criteria: * Locally uncontrolled disease * Metastatic disease * Patient with major cutaneous atrophy allowing only flap reconstruction * Patients under guardianship or trusteeship * Patients who objected to the research

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm female breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer female

Contacts and locations

Locations

  • Institut de Cancérologie de l'Ouest René Gauducheau

    Saint-Herblain, 44805, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.