Active — Not RecruitingNot Applicable

Safety and Clinical Performance of a Biological Matrix Used in Implant-based Breast Reconstruction

France112 participantsStarted 2021-10-04

Plain-language summary

The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Breast membranes used in breast reconstruction and to identify emerging risks in comparison to clinical data related to other treatment modalities. The present study will be a prospective, multicentric, non-randomized and non-controlled trial involving 112 patients followed for 24 months. The study will be conducted in France in 7 investigational centres.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient aged ≥18 years, * Patient with an indication of breast reconstruction after mastectomy (therapeutic or prophylactic), * Patient being informed of her participation to the study and of the follow-up visits, and having no objection to the clinical data collection and medical file access, * Patient being informed of the porcine origin of the device in advance of the procedure. Exclusion Criteria: * Patient with known hypersensitivity to porcine materials, * Patient with an existing infection at the site of implantation, * Patient having refused to participate to the study, * Patient refusing to return for the follow-up visits, * Patient who is pregnant.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of adverse events. Main complications of interest: infection, cellulitis, seroma, hematoma, skin flap-nipple necrosis, delayed wound healing, wound dehiscence, red breast syndrome, capsular contracture, implant related

Timeframe: From the surgical procedure throughout the entire 24-month follow-up period

Trial details

NCT IDNCT05031962

SponsorMeccellis Biotech

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-10

View on ClinicalTrials.gov More Breast Reconstruction Following Mastectomy trials