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Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms

  • Breast Reconstruction Following Mastectomy

NCT number NCT05031962
Study type Observational
Source Meccellis Biotech
Contact Claire CISTERNI, PhD
Phone +33 (0)6 68 13 76 26
Email [email protected]
Status Not yet recruiting
Phase
Start date September 2021
Completion date September 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02775409 - Prospective Trial of Subcutaneous Versus Subpectoral 2-Staged Implant-Based Breast Reconstruction N/A
Not yet recruiting NCT04874402 - Prepectoral vs Partial Subpectoral Two-Stage Implant-Based Breast Reconstruction N/A