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REGENERA Implant in Excised Non-Malignant Breast Lesions

NCT04131972 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-02-08

No results posted yet for this study

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.

Conditions

  • Benign Breast Disease

Interventions

DEVICE

REGENERA

REGENERA breast implant

Sponsors & Collaborators

  • Tensive SRL

    lead INDUSTRY

Principal Investigators

  • Manuela Roncella, MD · Azienda Ospedaliero, Universitaria Pisana

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-11-11
Primary Completion
2021-11-27
Completion
2021-11-27

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 NCT04131972 on ClinicalTrials.gov