CompletedNot Applicable

REGENERA Implant in Excised Non-Malignant Breast Lesions

Italy15 participantsStarted 2019-11-11

Plain-language 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.

Who can participate

Age range

20 Years – 85 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Female patients aged 20-85 years
. Patients eligible for excision or lumpectomy, as per current surgical guidelines
. Volume deficit compatible with an implant volume of 70 cc
. Adequate hematopoietic functions
. Good general health and mentally sound
. Confirmation of non-malignant lesion (B2 and B3) with no discordance between biopsy and radiological imaging
. Patients able and willing to give written informed consent form

Exclusion criteria

. Pregnant or breastfeeding women or women who have nursed a child three months within enrolment in the study
. Non-malignant lesions (B2 and B3) with discordance between biopsy and radiological imaging
. Infection of the surgical site confirmed pre-operatively by clinical examination
. Acute or chronic severe renal insufficiency (creatinine values \< 180 μmol/L)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cumulative number of all Serious Adverse Events

Timeframe: at 6 months from implantion of the device

Trial details

NCT IDNCT04131972

SponsorTensive SRL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-11-27

View on ClinicalTrials.gov More Benign Breast Disease trials