REGENERA Implant in Localized Non-malignant Breast Lesions Treated by Excision or Lumpectomy - Long-term Follow-up
A Pilot Study of REGENERA Implant in Localized Non-malignant Breast Lesions Treated by Excision or Lumpectomy - Long-term Follow-up
1 other identifier
observational
14
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 27, 2021
CompletedFirst Submitted
Initial submission to the registry
September 6, 2022
CompletedFirst Posted
Study publicly available on registry
September 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 17, 2026
February 8, 2024
February 1, 2024
4.8 years
September 6, 2022
February 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of adverse events
Rate of adverse events associated with the device (REGENERA implant)
54 months
Interventions
Observational study of a device implanted in a previous clinical study
Eligibility Criteria
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
You may qualify if:
- Patients treated with REGENERA according to protocol Tens-BBC/001/2017
- Patients able and willing to give written informed consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tensive SRLlead
- Advice Pharma Group srlcollaborator
Study Sites (1)
Unità Operativa di Senologia (Breast Surgery Unit), Ospedale Santa Chiara
Pisa, 56100, Italy
Related Publications (1)
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.
PMID: 41014462DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manuela Roncella, MD
Unità Operativa di Senologia (Breast Surgery Unit), Ospedale Santa Chiara
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2022
First Posted
September 8, 2022
Study Start
July 27, 2021
Primary Completion (Estimated)
May 17, 2026
Study Completion (Estimated)
May 17, 2026
Last Updated
February 8, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share