Breast Reconstruction Following MastectomyNCT05031962
Safety and Clinical Performance of a Biological Matrix Used in Implant-based Breast Reconstruction
An observational study of Breast Reconstruction Following Mastectomy, run by Meccellis Biotech at 10 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction Following Mastectomy
- What is being tested?
- CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)
- Type of treatment
- Medical device
- How many people
- 112 participants
- Where
- 10 sitesFrance
- Study dates
- 4 Oct 2021to 22 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Institut Bergonié
Bordeaux, 33076
Hôpital Ambroise Paré
Boulogne-Billancourt, 92100
Hôpitaux civils de Colmar
Colmar, 68024
Centre Oscar Lambret
Lille, 59000
Centre Léon Bérard
Lyon, 69373
Hôpital Européen Georges Pompidou
Paris, 75015
Hôpital Tenon
Paris, 75020
Institut de Cancérologie de l'Ouest - Site René Gauducheau
Saint-Herblain, 44 805
IUCT Oncopole
Toulouse, 31059
lnstitut Gustave Roussy
Villejuif, 94800
About this study
Official title: Porcine Acellular Dermal Matrix (PADM)-Assisted Implant-based Breast Reconstruction: a Prospective Observational Study
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.
Read the detailed 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.
- Being tested
- CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)
- Keywords
- Breast reconstruction, Biological membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)Device
Biological membrane used in breast reconstruction
| Study group | Role | What they receive |
|---|---|---|
| CELLIS Breast (Porcine Acellular Dermal Matrix, PADM) | Implant-based breast reconstruction following mastectomy using the CELLIS Breast matrix Receives: Device: CELLIS Breast (Porcine Acellular Dermal Matrix, PADM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Described at each visit
Measured: 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).
Percentage of each modality and VAS score described at each visit
Measured: 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).
Described at each visit
Measured: At the 10-day, 30-day, 3-month, 12-month and 24-month follow-up visits
Patient analgesics consumption
Percentage of analgesics consumption with a Cochrane-Armitage trend test.
Measured: 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.
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
Measured: At baseline and at 24 month
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
Measured: During the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start4 Oct 2021
- Primary completion22 Sep 2026
- Study completion22 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Reconstruction Following MastectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meccellis Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael ATLAN, MD, Principal investigator, Hôpital Tenon, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031962
- Sponsor's protocol ID
- BR_01_CIP
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2021
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Porcine Acellular Dermal Matrix (PADM)-Assisted Implant-based Breast Reconstruction: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05031962
- Acronym / sponsor ID
- BR_01_CIP
- Keywords
- Breast reconstruction, Biological membrane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Meccellis BiotechIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 22 Sep 2026 (actual)
- Study completion
- 22 Sep 2026 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CELLIS Breast (Porcine Acellular Dermal Matrix, PADM) | – | Device: CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)Implant-based breast reconstruction following mastectomy using the CELLIS Breast matrix |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)Biological membrane used in breast reconstruction | Device | CELLIS Breast (Porcine Acellular Dermal Matrix, PADM) |
Primary outcome
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
Time frame: From the surgical procedure throughout the entire 24-month follow-up period
Percentage
6 secondary outcomes
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).
Time frame: 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).
Time frame: 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).
Time frame: At the 10-day, 30-day, 3-month, 12-month and 24-month follow-up visits
Patient analgesics consumption
Time frame: 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.
Time frame: At baseline and at 24 month
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.
Time frame: During the surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Reconstruction Following Mastectomy
Recruiting
Comparison of Mastectomy Expander Trial
Mastectomy and Breast Reconstruction, Tissue Expander Based Breast Reconstruction
Not yet recruiting
Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction
Breast Reconstruction After Mastectomy
RecruitingPhase 3
Trial Of PreoperAtive Radiation (TOPAz): A Randomized Trial Comparing Hypofractionated Versus Conventionally Fractionated Preoperative Radiation Followed by Mastectomy With Immediate Autologous Breast Reconstruction With Integrated Tissue Nanomechanical Phenotype Evaluation
Breast Cancer
Not yet recruiting
Synthetic Electrospun Fiber Matrix in Abdominal Wall Donor Sites for Breast Reconstruction
Breast Reconstruction, Deep Inferior Epigastric Perforator
Not yet recruitingPhase 4
Does Nerve Grafting Improve Sensation After Nipple-Sparing Mastectomy With Implant Reconstruction?
Breast Reconstruction Following Mastectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael ATLAN, MD principal investigator
Hôpital Tenon, Paris, France
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Reconstruction Following Mastectomy, run by Meccellis Biotech at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: From the surgical procedure throughout the entire 24-month follow-up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.