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

NCT05533099 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 14

Last updated 2024-02-08

No results posted yet for this study

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.

Conditions

  • Breast Diseases

Interventions

OTHER

Observational study

Observational study of a device implanted in a previous clinical study

Sponsors & Collaborators

  • Advice Pharma Group srl

    collaborator INDUSTRY

  • Tensive SRL

    lead INDUSTRY

Principal Investigators

  • Manuela Roncella, MD · Unità Operativa di Senologia (Breast Surgery Unit), Ospedale Santa Chiara

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-27
Primary Completion
2026-05-17
Completion
2026-05-17

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05533099 on ClinicalTrials.gov