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Safety and Performance of REGENERA Breast Implant in Women Affected by Malignant Breast Lesion Treated by Lumpectomy

NCT05941299 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2024-11-22

No results posted yet for this study

Summary

The goals of this clinical trial are:

* demonstrate the safety of REGENERA breast implant in patients undergoing lumpectomy of malignant breast lesions
* demonstrate the safety and performance of REGENERA in terms of investigator's satisfaction, potential interference with current standard-of-care imaging techniques and occurrence of device-related serious adverse events.

Conditions

  • Mastectomy, Segmental
  • Breast Neoplasm Malignant Female

Interventions

DEVICE

REGENERA breast implant implantation

Each patient will perform 13 study visits, and at each visit, all necessary study procedures will be performed according to the clinical investigation plan: * Screening * Pre-surgery treatment * Surgery and study device implant * Post-surgery follow-up

Sponsors & Collaborators

  • Tensive SRL

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-29
Primary Completion
2025-02-28
Completion
2029-12-30

Countries

  • Italy
  • Spain

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 NCT05941299 on ClinicalTrials.gov