Breast DiseasesNCT05533099
REGENERA Implant in Localized Non-malignant Breast Lesions Treated by Excision or Lumpectomy - Long-term Follow-up
An observational study of Breast Diseases, run by Tensive SRL at 1 site in Italy.
Trial summary
In a previous first-in-human (FIH) study we assessed safety and performance of REGENERA in 15 patients treated for breast deformities following excision or lumpectomy. The technique was minimally invasive, easily repeated and associated with minimal surgical morbidity. Read more about this study
- Who is it for?
- Ages 20 to 85 years, women only
- Conditions the study is for
- Breast Diseases
- What is being tested?
- Observational study
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jul 2021to 22 May 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 20 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female adult subjects diagnosed with localized, non-malignant breast lesions, who underwent surgery with REGENERA implant after excision or lumpectomy of breast tissue, according to protocol Tens-BBC/001/2017
Who may be able to join
- Patients treated with REGENERA according to protocol Tens-BBC/001/2017
- Patients able and willing to give written informed consent form
Who cannot join
- There are no formal exclusion criteria for participation, as this LTFU study aims at following all the patients who have completed protocol Tens-BBC/001/2017, subject to informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unità Operativa di Senologia (Breast Surgery Unit), Ospedale Santa Chiara
Pisa, Pisa, 56100
About this study
Official title: A Pilot Study of REGENERA Implant in Localized Non-malignant Breast Lesions Treated by Excision or Lumpectomy - Long-term Follow-up
In a previous first-in-human (FIH) study we assessed safety and performance of REGENERA in 15 patients treated for breast deformities following excision or lumpectomy. The technique was minimally invasive, easily repeated and associated with minimal surgical morbidity.
It is important to assess whether the positive safety and performance results obtained during the initial 6 months post- surgery are maintained in the long-term, for up to 5 years after surgery.
In this long-term follow-up study we will assess long-term safety and performance of REGENERA implant after excision or lumpectomy of breast tissue in patients with non-malignant lesions.
Read the detailed description
REGENERA is a polymeric bioresorbable scaffold. The REGENERA matrix is characterized by an interconnected open pore/void structure, having average pore/void diameter from 0.3 to 6.5 mm and local thickness of 30 μm ± 20 μm (μCT 50, SCANCO Medical AG, Brüttisellen, Switzerland). A network of channels is embedded into the porous structure according to a specific pattern, where the channels are interconnected with the porous structure.
The biomaterial constituting REGENERA is composed of a patented biodegradable cross-linked poly(urethane-ester- ether) foam coated with a bio adhesive macromolecule [Poly(L- lysine); PLL] and hydrophobized by Oleic acid (18:1 n-9), a monounsaturated fatty acid.
The shape and geometry of REGENERA have been set to facilitate its insertion to the implantation site and to fulfill the volume deficit caused by excision of lesioned soft tissue after lumpectomy.
REGENERA is a polymeric bioresorbable scaffold intended to support the ingrowth of the patient's soft tissue when used to restore the natural appearance of the breast after surgical removal of benign and malignant breast lesions, up to 200 cc in volume.
In this long-term follow-up study we will assess long-term safety and performance of REGENERA implant after excision or lumpectomy of breast tissue in patients with non-malignant lesions.
REGENERA is the first medical device designed to restore a natural breast, after breast-conserving surgery (lumpectomy). As shown by the preliminary results of the FIH pilot study, a natural shape and feeling could be achieved, based on the patient's soft tissue growth ability, in a single step, easy-to- adopt and, potentially, cost saving procedure, for the healthcare stakeholders. The few post-operative complications combined with the positive psychological impact generated by the existence of a valid reconstructive option after lumpectomy, has the potential to improve the patients' quality of life, during and after post-surgery recovery.
Because all of that, the purpose of this long-term follow-up study is to assess whether REGENERA does not cause long-term safety issues and confirms its performance in the long-term.
- Conditions
- Breast Diseases
- Being tested
- Observational study
- Medical subject headings
- Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Observational study of a device implanted in a previous clinical study
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adverse events
Rate of adverse events associated with the device (REGENERA implant)
Measured: 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start27 Jul 2021
- Primary completion17 May 2026
- Study completion22 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tensive SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Advice Pharma Group srl
- Responsible party
- Sponsor
- Investigators
- Matteo Ghilli, MD, Principal investigator, Unità Operativa di Senologia (Breast Surgery Unit), Ospedale Santa Chiara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533099
- Sponsor's protocol ID
- Tens-BBC/002/2020
- Status last verified
- Jul 2026
- First submitted
- 6 Sep 2022
- 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
Mariniello MD, Roncella M, Mazzotta D, Gerges I, Colizzi L, Tamplenizza M, Tocchio A, Martello F, Ghilardi M, Cossu MC, Danti S, Ghilli M. 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. Breast Cancer. 2026 Jan;33(1):111-122. doi: 10.1007/s12282-025-01780-w. Epub 2025 Sep 27.
PubMed 41014462
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of REGENERA Implant in Localized Non-malignant Breast Lesions Treated by Excision or Lumpectomy - Long-term Follow-up
- ClinicalTrials.gov ID
- NCT05533099
- Acronym / sponsor ID
- Tens-BBC/002/2020
- Conditions
- Breast Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Tensive SRLIndustry (pharma, biotech, devices)
- Collaborators
- Advice Pharma Group srl
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 17 May 2026 (actual)
- Study completion
- 22 May 2026 (actual)
- First posted
- 8 Sep 2022 (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.
In a previous first-in-human (FIH) study we assessed safety and performance of REGENERA in 15 patients treated for breast deformities following excision or lumpectomy. The technique was minimally invasive, easily repeated and associated with minimal surgical morbidity.
It is important to assess whether the positive safety and performance results obtained during the initial 6 months post- surgery are maintained in the long-term, for up to 5 years after surgery.
In this long-term follow-up study we will assess long-term safety and performance of REGENERA implant after excision or lumpectomy of breast tissue in patients with non-malignant lesions.
Detailed description
REGENERA is a polymeric bioresorbable scaffold. The REGENERA matrix is characterized by an interconnected open pore/void structure, having average pore/void diameter from 0.3 to 6.5 mm and local thickness of 30 μm ± 20 μm (μCT 50, SCANCO Medical AG, Brüttisellen, Switzerland). A network of channels is embedded into the porous structure according to a specific pattern, where the channels are interconnected with the porous structure.
The biomaterial constituting REGENERA is composed of a patented biodegradable cross-linked poly(urethane-ester- ether) foam coated with a bio adhesive macromolecule [Poly(L- lysine); PLL] and hydrophobized by Oleic acid (18:1 n-9), a monounsaturated fatty acid.
The shape and geometry of REGENERA have been set to facilitate its insertion to the implantation site and to fulfill the volume deficit caused by excision of lesioned soft tissue after lumpectomy.
REGENERA is a polymeric bioresorbable scaffold intended to support the ingrowth of the patient's soft tissue when used to restore the natural appearance of the breast after surgical removal of benign and malignant breast lesions, up to 200 cc in volume.
In this long-term follow-up study we will assess long-term safety and performance of REGENERA implant after excision or lumpectomy of breast tissue in patients with non-malignant lesions.
REGENERA is the first medical device designed to restore a natural breast, after breast-conserving surgery (lumpectomy). As shown by the preliminary results of the FIH pilot study, a natural shape and feeling could be achieved, based on the patient's soft tissue growth ability, in a single step, easy-to- adopt and, potentially, cost saving procedure, for the healthcare stakeholders. The few post-operative complications combined with the positive psychological impact generated by the existence of a valid reconstructive option after lumpectomy, has the potential to improve the patients' quality of life, during and after post-surgery recovery.
Because all of that, the purpose of this long-term follow-up study is to assess whether REGENERA does not cause long-term safety issues and confirms its performance in the long-term.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female adult subjects diagnosed with localized, non-malignant breast lesions, who underwent surgery with REGENERA implant after excision or lumpectomy of breast tissue, according to protocol Tens-BBC/001/2017
Key inclusion criteria (2 listed)
- Patients treated with REGENERA according to protocol Tens-BBC/001/2017
- Patients able and willing to give written informed consent form
Key exclusion criteria (1 listed)
- There are no formal exclusion criteria for participation, as this LTFU study aims at following all the patients who have completed protocol Tens-BBC/001/2017, subject to informed consent.
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 |
|---|---|---|
| Observational studyObservational study of a device implanted in a previous clinical study | Other | – |
Primary outcome
Rate of adverse events
Time frame: 54 months
Rate of adverse events associated with the device (REGENERA implant)
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 22 Jul 2026.
- Derived from this study: PubMed 41014462Mariniello MD, Roncella M, Mazzotta D, Gerges I, Colizzi L, Tamplenizza M, Tocchio A, Martello F, Ghilardi M, Cossu MC, Danti S, Ghilli M. 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. Breast Cancer. 2026 Jan;33(1):111-122. doi: 10.1007/s12282-025-01780-w. Epub 2025 Sep 27.
- Individual participant dataSharing planned: No
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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.
Matteo Ghilli, MD principal investigator
Unità Operativa di Senologia (Breast Surgery Unit), Ospedale Santa Chiara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Diseases, run by Tensive SRL at 1 site in Italy.
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 2 inclusion and 1 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 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 1 site in Italy. 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 (time frame: 54 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 NCT05533099, 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.