Breast Reconstruction Following Mastectomy Clinical Trial
Official title:
Porcine Acellular Dermal Matrix (PADM)-Assisted Implant-based Breast Reconstruction: a Prospective Observational Study
NCT number | NCT05031962 |
Other study ID # | BR_01_CIP |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 4, 2021 |
Est. completion date | October 2026 |
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.
Status | Recruiting |
Enrollment | 112 |
Est. completion date | October 2026 |
Est. primary completion date | October 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Institut Bergonié | Bordeaux | |
France | Hôpital Ambroise Paré | Boulogne-Billancourt | |
France | Hôpitaux civils de Colmar | Colmar | |
France | Centre Oscar Lambret | Lille | |
France | Centre Léon Bérard | Lyon | |
France | Hôpital Européen Georges Pompidou | Paris | |
France | Hôpital Tenon | Paris | |
France | Institut de Cancérologie de l'Ouest - Site René Gauducheau | Saint-Herblain | |
France | IUCT Oncopole | Toulouse | |
France | lnstitut Gustave Roussy | Villejuif |
Lead Sponsor | Collaborator |
---|---|
Meccellis Biotech |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Percentage | From the surgical procedure throughout the entire 24-month follow-up period | |
Secondary | Patient aesthetic evaluation evaluated by Visual Analog Scale (VAS). The suppleness of the reconstruction will be evaluated (natural-hard): VAS score from 1 to 10 (1=very bad suppleness, breast hard; 10=excellent suppleness-natural breast). | Described at each visit | At the 3, 12 and 24-month follow-up visits | |
Secondary | Surgeon aesthetic evaluation: satisfaction related to the quality of the reconstruction (very good, good, fair, bad), suppleness (Visual Analog Scale score from 1 to 10 with 10=excellent suppleness) and symmetry (very good, good, fair, bad). | Percentage of each modality and VAS score described at each visit | At the 3, 12 and 24-month follow-up visits | |
Secondary | Patient-reported pain using a visual analogue scale (VAS) scored from 0 to 10 (0=no pain; 10=worse pain). | Described at each visit | At the 10-day, 30-day, 3-month, 12-month and 24-month follow-up visits | |
Secondary | Patient analgesics consumption | Percentage of analgesics consumption with a Cochrane-Armitage trend test. | At the 10-day, 30-day, 3-month, 12-month and 24-month follow-up visits | |
Secondary | Quality of life (QoL) by the use of the SF-36 questionnaire. | Change from screening of each domain score and total score at 24-month. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 with lower scores = more disability, and higher scores = less disability | At baseline and at 24 month | |
Secondary | Description of device deficiency: inadequacy of a medical device with respects to its identity, quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequate labelling. | Summarized and listed | During the surgical procedure |
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