Health TrialsbyHealthPanel

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

ConditionsMastectomy, SegmentalBreast Neoplasm Malignant Female
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-70
SponsorTensive SRL

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female adult subject aged 40-70 years.

monolateral nodular infiltrative carcinoma,

without microcalcification,

single or multifocal,

Disqualifiers

Subject with actual concomitant benign breast lesion (B2 and B3), unless present in the same mammary quadrant or in the contralateral breast.

Subject with actual concomitant malignancies, lobular neoplasm, metastatic breast carcinoma, sarcoma, malignant phyllodes lesions, or Paget's disease.

Axillary dissection planned as part of the breast lesion surgery.

History of surgery, chemotherapy, neoadjuvant chemotherapy, or irradiation of the breast parenchyma object of the study.

Trial design

Design model

Single group

Treatments tested in this trial

  • REGENERA breast implant implantation

    Device

    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

Treatment groups

92 Participants
are divided into 1 treatment group
Group A: REGENERA breast implant implantationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of adverse events (AEs) with a causal relationship to REGENERA at 3 months.

The rate of AEs with a causal relationship to REGENERA should be \<5% at 3 months after implant.

Time frame
3 months

Secondary outcomes

1

Mean investigator's satisfaction on the implanting procedure at 1week.

At least 7 in a 0-10 Visual Analogue Scale, VAS.

Time frame
1 week after implant
2

Mean investigator's satisfaction on REGENERA usability during surgery at 1 week.

At least 40 in an "ad hoc" questionnaire (12-60 scale).

Time frame
1 week after implant
3

Mean investigator's satisfaction on overall surgical procedure and clinical outcome of the patient at 12 months.

At least 7 in a 0-10 Visual Analogue Scale, VAS.

Time frame
12 months
4

Number of interference events of REGENERA with ultrasound imaging technique, through the completion of a questionnaire by the investigators.

An imaging evaluation questionnaire will be provided for investigators to fill out.

Time frame
After 6 and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tensive SRL

Lead sponsor

Source ClinicalTrials.gov
Apply now