Benign Breast DiseaseNCT04131972
REGENERA Implant in Excised Non-Malignant Breast Lesions
A study testing REGENERA in people with Benign Breast Disease, run by Tensive SRL at 1 site in Italy.
Trial summary
The purpose of this First-in-Human pilot study is to evaluate the safety and performance of REGENERA breast implant in a selected cohort of patients with non- malignant breast lesions treated with excision or lumpectomy in whom the tissue removed is replaced by REGENERA. Read more about this study
- Who is it for?
- Ages 20 to 85 years, women only
- Conditions the study is for
- Benign Breast Disease
- What is being tested?
- REGENERA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 11 Nov 2019to 27 Nov 2021
- Phase
- Interventional
- 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
Who may be able to join
- Female patients aged 20-85 years
- Patients eligible for excision or lumpectomy, as per current surgical guidelines
- Volume deficit compatible with an implant volume of 70 cc
- Adequate hematopoietic functions
- Good general health and mentally sound
- Confirmation of non-malignant lesion (B2 and B3) with no discordance between biopsy and radiological imaging
- Patients able and willing to give written informed consent form
Who cannot join
- Pregnant or breastfeeding women or women who have nursed a child three months within enrolment in the study
- Non-malignant lesions (B2 and B3) with discordance between biopsy and radiological imaging
- Infection of the surgical site confirmed pre-operatively by clinical examination
- Acute or chronic severe renal insufficiency (creatinine values < 180 μmol/L)
- History of severe asthma or allergies (including to anaesthetics or contrast media)
- Autoimmune disease
Show all 14Show fewer
- Subject with actual concomitant malignancies, lobular neoplasm, metastatic breast carcinoma, sarcoma, malignant phyllodes lesions, or Paget's disease
- Subject who are known to be carriers of BCRA mutation
- Inability to undergo MRI or allergy to contrast media
- Systemic infections in active phase
- Immunocompromised patients (HIV)
- Subjects who have participated in another study within the past 3 months
- Patients who received immunosuppressant therapy in the last 3 months
- Non-collaborative patients (severe physical disabilities or psychiatric disorders, as per specialist opinion).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of REGENERA Implant in Localized Non- Malignant Breast Lesions Treated by Excision or Lumpectomy
The purpose of this First-in-Human pilot study is to evaluate the safety and performance of REGENERA breast implant in a selected cohort of patients with non- malignant breast lesions treated with excision or lumpectomy in whom the tissue removed is replaced by REGENERA.
Read the detailed description
This is a pre-market, single center, interventional, open label, non-comparative, pilot first-in-human study on adult female patients with localized non-malignant breast lesion. This study will include an enrollment period of 12 months and 6 months study duration per patient.
The primary objective of this study is to demonstrate the safety profile of a new breast implant (REGENERA) in excision or lumpectomy of non-malignant breast lesions.
The secondary objectives of this study are:
- To assess the safety of the implant procedure
- To assess the feasibility of the implant procedure
- To evaluate the performance of REGENERA breast implant:
- In replacing the removed tissue
- In potential interference with current diagnostic standard of care imaging procedures
- On patient's quality of life and satisfaction
- On investigator's satisfaction.
- Conditions
- Benign Breast Disease
- Being tested
- REGENERA
- Keywords
- Lumpectomy, Bio-absorbable
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGENERADevice
REGENERA breast implant
| Study group | Role | What they receive |
|---|---|---|
| Single arm 1 | Experimental | Each patient will be planned to perform 7 study visits and at the second visit excision / lumpectomy and REGENERA implant will be performed during the same surgical intervention. Receives: Device: REGENERA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative number of all Serious Adverse Events
Cumulative number of Serious Adverse Events collected throughout the study and associated with the REGENERA implant device (Adverse Device Effects)
Measured: at 6 months from implantion of the device
Secondary outcomes (6)
Measurement of changes in breast appeareance before and after surgery through antropomorphic chest parameters
Assess breast appearance before and after surgery with photo and chest measurement. In particular, the following measures, in cm, will be evaluated: sternal notch to nipple (SN), nipple to inframammary fold (NF), nipple to sternum (NM), the areola diameter and the ptosis grade.
Measured: at 2 weeks before the implantation of the device (Day 0), 1 week from Day 0, 3 months from Day 0, 6 months from Day 0
Measurement of the reduction of reliability of the currently used diagnostic imaging techniques
Assess the potential interference with current, standard- of-care imaging techniques by evaluation of the following factors: (1) for ultrasound, the possible attenuation of the acoustic beam preventing the visualization of the tissue behind the implant; (2) for magnetic resonance imaging, possible creation, caused by the implant, of images mimicking a pre-invasive or invasive lesion.
Measured: at 1 week from the implantation of the device (Day 0), 2 weeks from Day 0, 1 month from Day 0, 3 months from Day 0 and 6 months from Day 0
Patient Quality of Life measured through Breast-Q questionnaire
Measure changes in patient's Quality of Life (QoL) and satisfaction through Breast-Q™ questionnaire (pre- and post-operative Breast Conserving Therapy (BCT) module version 2.0) after surgery versus baseline (prior implantation surgery).
Breast-Q™ questionnaire includes 7 scales measuring (i) breast satisfaction, (ii) psychosocial well-being, (iii) physical breast well-being, (iv) sexual well-being, (v) patient experience satisfaction with the surgeon, (vi) patient experience satisfaction with the medical equip and (vii) patient experience satisfaction with the hospital staff. Each scale is evaluated by defined questions where the patient has to answer by a numeric scale. For example: "1", "non of the time"; "2", "a little of the time"; "3", some of the time; "4", "most of the time"; "5", "all of the time". Once the questions are answered, a conversion table is applied to convert the raw scale summed score into a score from 0 (worst) to 100 (best).
Measured: at 1 month from the implantation of the device (Day 0), 6 months from Day 0 versus 2 weeks before Day 0
Patient pain measurement through a Visual Analogue Scale
Assess pain intensity with a Visual Analogue Scale (VAS) at each study visit. The VAS measure will be made through a cross (X) that the patient has to put along a bar. The left margin of the bar corresponds to "no pain" (0 score) and the right margin to "worst pain" (10 score).
Measured: at 2 weeks before the implantation of the device (Day 0), Day 0, 1 week from Day 0, 2 weeks from Day 0, 1 month from Day 0, 3 months from Day 0 and 6 months from Day 0
Measure of the Investigator's satisfaction on the implantation procedure, through a Visual Analogue Scale (VAS) and an ad-hoc questionnaire
Assess investigator's satisfaction on the implantation procedure, through a Visual Analogue Scale (VAS) and an ad-hoc questionnaire (developed by the Sponsor), and on the REGENERA performance, through a VAS scale.
The VAS measure will be made through a cross (X) that the patient has to put along a bar. The left margin of the bar corresponds to "no pain" (0 score) and the right margin to "worst pain" (10 score).
The ad-hoc questionnaire has a unique scale made of 5 levels (1 corresponds to "strongly disagree" and 5 corresponds to "strongly agree") to be used for each question. As there are 12 questions, 12 is the minimum score and 60 is the maximum score as a sum of all answers.
Measured: implantation satisfaction (VAS + ad-hoc questionnaire) at the implantation of the device (Day 0) and REGENERA performance (VAS) at 6 months from Day 0
Cumulative number of all Adverse Events associated with the surgical procedure
Cumulative number of all Adverse Events associated with the surgical procedure: number of re-operations and / or explants due to seroma, hematoma, infection, wound dehiscence, skin retraction, acute inflammatory reactions, allergic reactions to the device, persistent pain.
Measured: at 6 months from the implantation of the device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start11 Nov 2019
- Primary completion27 Nov 2021
- Study completion27 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Benign Breast DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tensive SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manuela Roncella, MD, Principal investigator, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131972
- Sponsor's protocol ID
- Tens-BBC/001/2017
- Status last verified
- Feb 2022
- First submitted
- 14 May 2019
- Last updated
- 8 Feb 2022
- 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 41014462Mariniello MD, Ghilli M, Favati B, Gerges I, Colizzi L, Tamplenizza M, Tocchio A, Martello F, Ghilardi M, Cossu MC, Danti S, Roncella M. Cell-free biomimetic polyurethane-based scaffold for breast reconstruction following non-malignant lesion resection. A first-in-human study. Breast Cancer. 2023 Jul;30(4):559-569. doi: 10.1007/s12282-023-01446-5. Epub 2023 Mar 28.
PubMed 36977972
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. 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
- ClinicalTrials.gov ID
- NCT04131972
- Acronym / sponsor ID
- Tens-BBC/001/2017
- Conditions
- Benign Breast Disease
- Keywords
- Lumpectomy, Bio-absorbable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Tensive SRLIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 27 Nov 2021 (actual)
- Study completion
- 27 Nov 2021 (actual)
- First posted
- 18 Oct 2019 (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 purpose of this First-in-Human pilot study is to evaluate the safety and performance of REGENERA breast implant in a selected cohort of patients with non- malignant breast lesions treated with excision or lumpectomy in whom the tissue removed is replaced by REGENERA.
Detailed description
This is a pre-market, single center, interventional, open label, non-comparative, pilot first-in-human study on adult female patients with localized non-malignant breast lesion. This study will include an enrollment period of 12 months and 6 months study duration per patient.
The primary objective of this study is to demonstrate the safety profile of a new breast implant (REGENERA) in excision or lumpectomy of non-malignant breast lesions.
The secondary objectives of this study are:
- To assess the safety of the implant procedure
- To assess the feasibility of the implant procedure
- To evaluate the performance of REGENERA breast implant:
- In replacing the removed tissue
- In potential interference with current diagnostic standard of care imaging procedures
- On patient's quality of life and satisfaction
- On investigator's satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm 1 | Experimental | Device: REGENERAEach patient will be planned to perform 7 study visits and at the second visit excision / lumpectomy and REGENERA implant will be performed during the same surgical intervention. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients aged 20-85 years
- Patients eligible for excision or lumpectomy, as per current surgical guidelines
- Volume deficit compatible with an implant volume of 70 cc
- Adequate hematopoietic functions
- Good general health and mentally sound
Key exclusion criteria (14 listed)
- Pregnant or breastfeeding women or women who have nursed a child three months within enrolment in the study
- Non-malignant lesions (B2 and B3) with discordance between biopsy and radiological imaging
- Infection of the surgical site confirmed pre-operatively by clinical examination
- Acute or chronic severe renal insufficiency (creatinine values < 180 μmol/L)
- History of severe asthma or allergies (including to anaesthetics or contrast media)
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 |
|---|---|---|
| REGENERAREGENERA breast implant | Device | Single arm 1 |
Primary outcome
Cumulative number of all Serious Adverse Events
Time frame: at 6 months from implantion of the device
Cumulative number of Serious Adverse Events collected throughout the study and associated with the REGENERA implant device (Adverse Device Effects)
6 secondary outcomes
Measurement of changes in breast appeareance before and after surgery through antropomorphic chest parameters
Time frame: at 2 weeks before the implantation of the device (Day 0), 1 week from Day 0, 3 months from Day 0, 6 months from Day 0
Measurement of the reduction of reliability of the currently used diagnostic imaging techniques
Time frame: at 1 week from the implantation of the device (Day 0), 2 weeks from Day 0, 1 month from Day 0, 3 months from Day 0 and 6 months from Day 0
Patient Quality of Life measured through Breast-Q questionnaire
Time frame: at 1 month from the implantation of the device (Day 0), 6 months from Day 0 versus 2 weeks before Day 0
Patient pain measurement through a Visual Analogue Scale
Time frame: at 2 weeks before the implantation of the device (Day 0), Day 0, 1 week from Day 0, 2 weeks from Day 0, 1 month from Day 0, 3 months from Day 0 and 6 months from Day 0
Measure of the Investigator's satisfaction on the implantation procedure, through a Visual Analogue Scale (VAS) and an ad-hoc questionnaire
Time frame: implantation satisfaction (VAS + ad-hoc questionnaire) at the implantation of the device (Day 0) and REGENERA performance (VAS) at 6 months from Day 0
Cumulative number of all Adverse Events associated with the surgical procedure
Time frame: at 6 months from the implantation of the device
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 Feb 2022.
- 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.
- Derived from this study: PubMed 36977972Mariniello MD, Ghilli M, Favati B, Gerges I, Colizzi L, Tamplenizza M, Tocchio A, Martello F, Ghilardi M, Cossu MC, Danti S, Roncella M. Cell-free biomimetic polyurethane-based scaffold for breast reconstruction following non-malignant lesion resection. A first-in-human study. Breast Cancer. 2023 Jul;30(4):559-569. doi: 10.1007/s12282-023-01446-5. Epub 2023 Mar 28.
- 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.
Manuela Roncella, MD principal investigator
Azienda Ospedaliero, Universitaria Pisana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REGENERA in people with Benign Breast Disease, 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 7 inclusion and 14 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 Feb 2022. 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?
Cumulative number of all Serious Adverse Events (time frame: at 6 months from implantion of the device). 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 NCT04131972, which also lists 2 linked publications.
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 Feb 2022.