Informations générales (source: ClinicalTrials.gov)
Porcine Acellular Dermal Matrix (PADM)-Assisted Implant-based Breast Reconstruction: a Prospective Observational Study
Observational
Meccellis Biotech (Voir sur ClinicalTrials)
octobre 2021
octobre 2026
23 novembre 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Anna ILENKO | 26/02/2024 16:30:44 | Contact (sur clinicalTrials) | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Tenon | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Léon Bérard - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| Hôpital Ambroise Paré - 92100 - Boulogne-Billancourt - France | Contact (sur clinicalTrials) | ||||
| Hôpitaux civils de Colmar - 68024 - Colmar - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonié - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de l'Ouest - Site René Gauducheau - 44 805 - Saint-Herblain - France | Contact (sur clinicalTrials) | ||||
| IUCT Oncopole - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Femme
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.
- 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.
- 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.