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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-04

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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The study will be prospective, multicentric, single-arm observational (non-interventional) to evaluate the safety and performance of the CELLIS Breast membranes used in breast reconstruction following mastectomy.

All evaluations will be performed and products used according to the usual practice, without additional or unusual diagnostic, treatment and monitoring procedure.

The study will be conducted in France in 7 investigational centres including 112 patients scheduled for a breast reconstruction following mastectomy.

Each patient will participate in one assessment period including a preoperative visit, followed by the day of surgical procedure and a hospitalization period.

Patients will return for ambulatory visits on day 10 (+/- 5 days) and/or on day 30 (+/- 7 days), on month 3 (+/- 2 weeks), on month 12 (+/- 2 weeks) and on month 24 (+/-2 weeks) post-surgery.

CELLIS Breast is available in one thickness, in a variety of size and forms addressing multiple surgical techniques.

Conditions

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Breast Reconstruction Following Mastectomy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)

Implant-based breast reconstruction following mastectomy using the CELLIS Breast matrix

CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)

Intervention Type DEVICE

Biological membrane used in breast reconstruction

Interventions

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CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)

Biological membrane used in breast reconstruction

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No