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

NCT05031962 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 112

Last updated 2024-11-22

No results posted yet for this study

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.

Conditions

  • Breast Reconstruction Following Mastectomy

Interventions

DEVICE

CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)

Biological membrane used in breast reconstruction

Sponsors & Collaborators

  • Meccellis Biotech

    lead INDUSTRY

Principal Investigators

  • Michael ATLAN, MD · Hôpital Tenon, Paris, France

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-04
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05031962 on ClinicalTrials.gov