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Mastectomy, SegmentalNCT05941299

Safety and Performance of REGENERA Breast Implant in Women Affected by Malignant Breast Lesion Treated by Lumpectomy

A study testing REGENERA breast implant implantation in people with Mastectomy, Segmental and Breast Neoplasm Malignant Female, run by Tensive SRL at 9 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goals of this clinical trial are: demonstrate the safety of REGENERA breast implant in patients undergoing lumpectomy of malignant breast lesions demonstrate the safety and performance of REGENERA in terms of investigator's satisfaction, potential interference with current standard-of-care imaging techniques and… Read more about this study

Who is it for?
Ages 40 to 70 years, women only
What is being tested?
REGENERA breast implant implantation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
9 sitesin 2 countries
Study dates
29 Sep 2023to 30 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 40 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female adult subject aged 40-70 years.
  • Subject diagnosed with malignant breast lesion:
  • monolateral nodular infiltrative carcinoma,
  • without microcalcification,
  • single or multifocal,
  • included in an area with a maximum diameter of 4 cm,
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  • non-metastatic (M0).
  • Subject with clinically negative axilla.
  • Subject considered eligible for conservative breast surgery - BCS (Breast-Conserving Surgery, lumpectomy or quadrantectomy), leaving a volume deficit compatible with a REGENERA implant (available in two dried sizes) volume of 70 ml or 100 ml.
  • Confirmation of malignant lesion (pT1, pT2, pN0, pN1) with no discordance between biopsy and radiological imaging.
  • Adequate hematopoietic functions.
  • Good general health and mentally sound.
  • Subject able and willing to give written informed consent form.

Who cannot join

  • Subject with actual concomitant benign breast lesion (B2 and B3), unless present in the same mammary quadrant or in the contralateral breast.
  • Subject with actual concomitant malignancies, lobular neoplasm, metastatic breast carcinoma, sarcoma, malignant phyllodes lesions, or Paget's disease.
  • Axillary dissection planned as part of the breast lesion surgery.
  • History of surgery, chemotherapy, neoadjuvant chemotherapy, or irradiation of the breast parenchyma object of the study.
  • Skin retraction at the breast to be operated.
  • Infection of the surgical site confirmed pre-operatively by clinical examination.
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  • Abnormal blood sugar and glycosylated hemoglobin.
  • Hard smoker (more than 10 cigarettes a day).
  • Acute or chronic severe renal insufficiency (creatinine values >180 μmol/l).
  • History of severe asthma or allergies (including allergy to anesthetics or contrast media).
  • Autoimmune disease.
  • Subjects who are known to be carriers of BCRA mutation.
  • Inability to undergo MRI or allergy to contrast media.
  • Systemic infections in an active phase.
  • Immunocompromised patients (HIV).
  • Pregnant or breastfeeding woman or woman who has nursed a child within 3 months prior to enrolment in the study.
  • Subject who has participated in another interventional study within the past 3 months.
  • Subject who received immunosuppressant therapy in the last 3 months.
  • History of substance abuse (drug or alcohol).
  • Non-collaborative patients (severe physical disabilities or psychiatric disorders, as per specialist opinion).

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

Italy8 sites

  • IRCCS Humanitas Istituto Clinico Catanese

    Catania, 95045

  • IEO Istituto Europeo di Oncologia

    Milan, 20141

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • ICS Maugeri IRCCS

    Pavia, 27100

  • A.O.U. Pisana - Ospedale Santa Chiara

    Pisa, 56126

  • Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

  • IRCCS Humanitas Research Hospital

    Rozzano, Milano, 20089

  • Istituto Oncologico di Candiolo FPO-IRCCS

    Torino, 10060

Other trials in Italy

Spain1 site

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15001

Other trials in Spain

About this study

Official title: A Pivotal Study of REGENERA Implant in Malignant Breast Lesion Treated by Lumpectomy

The goals of this clinical trial are:

  • demonstrate the safety of REGENERA breast implant in patients undergoing lumpectomy of malignant breast lesions
  • demonstrate the safety and performance of REGENERA in terms of investigator's satisfaction, potential interference with current standard-of-care imaging techniques and occurrence of device-related serious adverse events.
Read the detailed description

Participants will perform 13 study visits, and at each visit, all necessary study procedures will be performed according to the clinical investigation plan:

  • Screening
  • Pre-surgery treatment
  • Surgery and study device implant
  • Post-surgery follow-up up to 5 years
Being tested
REGENERA breast implant implantation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REGENERA breast implant implantationDevice

    Each patient will perform 13 study visits, and at each visit, all necessary study procedures will be performed according to the clinical investigation plan:

    • Screening
    • Pre-surgery treatment
    • Surgery and study device implant
    • Post-surgery follow-up
Study groups in NCT05941299
Study groupRoleWhat they receive
REGENERA breast implant implantationExperimentalSingle monolateral breast implant
Receives: Device: REGENERA breast implant implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of adverse events (AEs) with a causal relationship to REGENERA at 3 months.

    The rate of AEs with a causal relationship to REGENERA should be <5% at 3 months after implant.

    Measured: 3 months

Secondary outcomes (8)

  1. Mean investigator's satisfaction on the implanting procedure at 1week.

    At least 7 in a 0-10 Visual Analogue Scale, VAS.

    Measured: 1 week after implant

  2. Mean investigator's satisfaction on REGENERA usability during surgery at 1 week.

    At least 40 in an "ad hoc" questionnaire (12-60 scale).

    Measured: 1 week after implant

  3. Mean investigator's satisfaction on overall surgical procedure and clinical outcome of the patient at 12 months.

    At least 7 in a 0-10 Visual Analogue Scale, VAS.

    Measured: 12 months

  4. Number of interference events of REGENERA with ultrasound imaging technique, through the completion of a questionnaire by the investigators.

    An imaging evaluation questionnaire will be provided for investigators to fill out.

    Measured: After 6 and 12 months

  5. Number of interference events of REGENERA with mammography imaging technique, through the completion of a questionnaire by the investigators.

    An imaging evaluation questionnaire will be provided for investigators to fill out.

    Measured: After 12 months

  6. Number of interference events of REGENERA with MRI (with and without contrast) imaging technique, through the completion of a questionnaire by the investigators.

    An imaging evaluation questionnaire will be provided for investigators to fill out.

    Measured: After 6 and 18 months

  7. Rate of serious adverse events (SAEs) with a causal relationship to REGENERA after 3 months and up to 18 months.

    The rate of REGENERA-related SAEs should be <5% at each follow-up after 3 months and up to 18 months.

    Measured: After 3 months and up to 18 months

  8. Rate of SAEs with a causal relationship to REGENERA after 18 months and up to 5 years.

    The rate of REGENERA-related SAEs should be <7% at each follow-up after 18 months and up to 5 years.

    Measured: After 18 months and up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2023
  2. Study start29 Sep 2023
  3. Primary completion30 Dec 2028 (estimated)
  4. Study completion30 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
92 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05941299
Sponsor's protocol ID
Tens-BBC/003/2021
Status last verified
Sep 2025
First submitted
16 Jun 2023
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lisa AVE, Bottoni M, Ghilli M, Mariniello MD, Intra M, Belloni LM, Mattar D, Cossu MC, Montrone S, Tamplenizza M, Gerges I, Tocchio A, Acea B, Roncella M, Rietjens M. Volume replacement procedure adopting biomaterial: early considerations from a multicentric study. Updates Surg. 2025 Sep;77(5):1665-1671. doi: 10.1007/s13304-025-02212-2. Epub 2025 Apr 28.

    PubMed 40295450

Questions about this trial

What is this clinical trial studying?

A study testing REGENERA breast implant implantation in people with Mastectomy, Segmental and Breast Neoplasm Malignant Female, run by Tensive SRL at 9 sites in 2 countries.

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 13 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Italy, Spain. 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?

This study is still under way. Results are not available in the source record yet.

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 (AEs) with a causal relationship to REGENERA at 3 months. (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05941299, which also lists 1 linked publication.

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 22 Jul 2026.

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