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

NCT05031962 | Active Not Recruiting

• 1 other identifier: BR_01_CIP
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 10

Brief 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

Keywords

Breast reconstruction; Biological membrane

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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).

  At the 3, 12 and 24-month follow-up visits

• 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).

  At the 3, 12 and 24-month follow-up visits

• Patient-reported pain using a visual analogue scale (VAS) scored from 0 to 10 (0=no pain; 10=worse pain).

  At the 10-day, 30-day, 3-month, 12-month and 24-month follow-up visits

• Patient analgesics consumption

  At the 10-day, 30-day, 3-month, 12-month and 24-month follow-up visits

• Quality of life (QoL) by the use of the SF-36 questionnaire.

  At baseline and at 24 month

Study Arms (1)

CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)

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

Device: CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)

Interventions

CELLIS Breast (Porcine Acellular Dermal Matrix, PADM) DEVICE

Biological membrane used in breast reconstruction

CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Constitution and follow-up of a consecutive cohort of patients operated with the CELLIS Breast membranes based on the usual practices, the indication and the inclusion-exclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meccellis Biotech: lead

Study Sites (10)

Institut Bergonié

Bordeaux, 33076, France

Location

Hôpital Ambroise Paré

Boulogne-Billancourt, 92100, France

Location

Hôpitaux civils de Colmar

Colmar, 68024, France

Location

Centre Oscar Lambret

Lille, 59000, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Hôpital Tenon

Paris, 75020, France

Location

Institut de Cancérologie de l'Ouest - Site René Gauducheau

Saint-Herblain, 44 805, France

Location

IUCT Oncopole

Toulouse, 31059, France

Location

lnstitut Gustave Roussy

Villejuif, 94800, France

Location

Study Officials

• Michael ATLAN, MD

  Hôpital Tenon, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: September 2, 2021
• Study Start: October 4, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)