Evidence map›Paper›PMID 41014462›Full record

Trial reportBreast cancer (Tokyo, Japan)2026

Scaffold-based breast conserving surgery in patients with non-malignant breast lesions: long-term follow-up of a first-in-human pilot study on the REGENERA™ biomimetic breast implant.

Maria Donatella Mariniello, Manuela Roncella, Dionisia Mazzotta, Irini Gerges, Livio Colizzi, Margherita Tamplenizza, Alessandro Tocchio, Federico Martello, Maria Ghilardi, Maria Cristina Cossu and 2 more

2 registry-linked trialsAbstract readClinical TrialObservational Study
PubMed Publisher
In one paragraph

Trial report in Breast cancer (Tokyo, Japan), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04131972 nacompletednot on this map

A Pilot Study of REGENERA Implant in Localized Non- Malignant Breast Lesions Treated by Excision or Lumpectomy

TypeinterventionalSponsorTensive SRLRan2019 to 2021Enrolled15ConditionsBenign Breast DiseaseArmsREGENERA
NCT05533099 completednot on this map

A Pilot Study of REGENERA Implant in Localized Non-malignant Breast Lesions Treated by Excision or Lumpectomy - Long-term Follow-up

TypeobservationalSponsorTensive SRLRan2021 to 2026Enrolled14ConditionsBreast DiseasesArmsObservational study
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Maria Donatella MarinielloBreast Cancer Center, University Hospital of Pisa, Via Roma 57, 56126, Pisa, Italy. m.d.mariniello@gmail.com.ORCID http://orcid.org/0000-0002-5461-3510
Manuela RoncellaBreast Cancer Center, University Hospital of Pisa, Via Roma 57, 56126, Pisa, Italy.
Dionisia MazzottaBreast Cancer Center, University Hospital of Pisa, Via Roma 57, 56126, Pisa, Italy.
Irini GergesTensive SRL, Via Timavo 34, Milan, Italy.
Livio ColizziBreast Cancer Center, University Hospital of Pisa, Via Roma 57, 56126, Pisa, Italy.
Margherita TamplenizzaTensive SRL, Via Timavo 34, Milan, Italy.
Alessandro TocchioTensive SRL, Via Timavo 34, Milan, Italy.
Federico MartelloTensive SRL, Via Timavo 34, Milan, Italy.
Maria GhilardiBreast Cancer Center, University Hospital of Pisa, Via Roma 57, 56126, Pisa, Italy.
Maria Cristina CossuBreast Cancer Center, University Hospital of Pisa, Via Roma 57, 56126, Pisa, Italy.
Serena DantiDepartment of Civil and Industrial Engineering, University of Pisa, Largo L. Lazzarino 2, 56122, Pisa, Italy.
Matteo GhilliBreast Cancer Center, University Hospital of Pisa, Via Roma 57, 56126, Pisa, Italy.

Funding

European Commission H2020-EIC-SMEInst-2018-2020 (Grant agreement number: 812002)
6 · The paper itself

Abstract

backgroundFrequently, the breast surgeon must employ complex oncoplastic techniques (OBS) to guarantee optimal cosmetic results. The success of the REGENERA™ implant in combining the benefits of OBS with the simplicity of breast conserving surgery (BCS) has been previously reported in five patients with short follow-up. The goal of this study was to build on these promising data by reporting safety and efficacy results in a larger population with a longer follow-up.

methodsFifteen females with non-malignant breast lesions who underwent lumpectomy and implantation of REGENERA™ device, followed-up for six months, were included in this interventional FIH study. Fourteen of these, were included in a long-term observational study (LTFU) and followed-up for 24 months. Safety (incidence of adverse events [AEs]) and performance (changes in breast appearance, interference with imaging) of the device, and investigator and patient satisfaction were evaluated. Data from these two studies are reported herein. (Registered on clinicaltrials.gov: NCT05533099 and NCT04131972).

resultsA total of 113 AEs were reported. Only 3 (2.6%) were considered possibly device-related. The great majority (91,2%) were mild/moderate and only in one case the device was explanted. The REGENERA™ implant demonstrated high levels of performance, with an aesthetic score of 'Excellent' in 85.7% of patients, no interference with imaging, and high levels of patients and investigator satisfaction.

conclusionsData continue to be strongly supportive of the use of the REGENERA™ implant in BCS, further paving the way for an innovative surgical approach.

Indexed as

Breast ImplantationBreast ImplantsBreast NeoplasmsMastectomy, SegmentalAdultAgedFemaleFollow-Up StudiesHumansMiddle AgedPatient SatisfactionPilot ProjectsTissue ScaffoldsTreatment OutcomeBiomimetic scaffoldBreast conservation surgeryPerformanceSafetyTissue engineering

Identifiers

PMID41014462

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.