- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04131972
REGENERA Implant in Excised Non-Malignant Breast Lesions
A Pilot Study of REGENERA Implant in Localized Non- Malignant Breast Lesions Treated by Excision or Lumpectomy
Study Overview
Detailed Description
This is a pre-market, single center, interventional, open label, non-comparative, pilot first-in-human study on adult female patients with localized non-malignant breast lesion. This study will include an enrollment period of 12 months and 6 months study duration per patient.
The primary objective of this study is to demonstrate the safety profile of a new breast implant (REGENERA) in excision or lumpectomy of non-malignant breast lesions.
The secondary objectives of this study are:
- To assess the safety of the implant procedure
- To assess the feasibility of the implant procedure
To evaluate the performance of REGENERA breast implant:
- In replacing the removed tissue
- In potential interference with current diagnostic standard of care imaging procedures
- On patient's quality of life and satisfaction
- On investigator's satisfaction.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Pisa, Italy, 56126
- Azienda Ospedaliero Universitaria Pisana
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
- History of severe asthma or allergies (including to anaesthetics or contrast media)
- Autoimmune disease
- Subject with actual concomitant malignancies, lobular neoplasm, metastatic breast carcinoma, sarcoma, malignant phyllodes lesions, or Paget's disease
- Subject who are known to be carriers of BCRA mutation
- Inability to undergo MRI or allergy to contrast media
- Systemic infections in active phase
- Immunocompromised patients (HIV)
- Subjects who have participated in another study within the past 3 months
- Patients who received immunosuppressant therapy in the last 3 months
- Non-collaborative patients (severe physical disabilities or psychiatric disorders, as per specialist opinion).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Single arm 1
Each patient will be planned to perform 7 study visits and at the second visit excision / lumpectomy and REGENERA implant will be performed during the same surgical intervention.
|
REGENERA breast implant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative number of all Serious Adverse Events
Time Frame: at 6 months from implantion of the device
|
Cumulative number of Serious Adverse Events collected throughout the study and associated with the REGENERA implant device (Adverse Device Effects)
|
at 6 months from implantion of the device
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of changes in breast appeareance before and after surgery through antropomorphic chest parameters
Time Frame: at 2 weeks before the implantation of the device (Day 0), 1 week from Day 0, 3 months from Day 0, 6 months from Day 0
|
Assess breast appearance before and after surgery with photo and chest measurement.
In particular, the following measures, in cm, will be evaluated: sternal notch to nipple (SN), nipple to inframammary fold (NF), nipple to sternum (NM), the areola diameter and the ptosis grade.
|
at 2 weeks before the implantation of the device (Day 0), 1 week from Day 0, 3 months from Day 0, 6 months from Day 0
|
Measurement of the reduction of reliability of the currently used diagnostic imaging techniques
Time Frame: at 1 week from the implantation of the device (Day 0), 2 weeks from Day 0, 1 month from Day 0, 3 months from Day 0 and 6 months from Day 0
|
Assess the potential interference with current, standard- of-care imaging techniques by evaluation of the following factors: (1) for ultrasound, the possible attenuation of the acoustic beam preventing the visualization of the tissue behind the implant; (2) for magnetic resonance imaging, possible creation, caused by the implant, of images mimicking a pre-invasive or invasive lesion.
|
at 1 week from the implantation of the device (Day 0), 2 weeks from Day 0, 1 month from Day 0, 3 months from Day 0 and 6 months from Day 0
|
Patient Quality of Life measured through Breast-Q questionnaire
Time Frame: at 1 month from the implantation of the device (Day 0), 6 months from Day 0 versus 2 weeks before Day 0
|
Measure changes in patient's Quality of Life (QoL) and satisfaction through Breast-Q™ questionnaire (pre- and post-operative Breast Conserving Therapy (BCT) module version 2.0) after surgery versus baseline (prior implantation surgery). Breast-Q™ questionnaire includes 7 scales measuring (i) breast satisfaction, (ii) psychosocial well-being, (iii) physical breast well-being, (iv) sexual well-being, (v) patient experience satisfaction with the surgeon, (vi) patient experience satisfaction with the medical equip and (vii) patient experience satisfaction with the hospital staff. Each scale is evaluated by defined questions where the patient has to answer by a numeric scale. For example: "1", "non of the time"; "2", "a little of the time"; "3", some of the time; "4", "most of the time"; "5", "all of the time". Once the questions are answered, a conversion table is applied to convert the raw scale summed score into a score from 0 (worst) to 100 (best). |
at 1 month from the implantation of the device (Day 0), 6 months from Day 0 versus 2 weeks before Day 0
|
Patient pain measurement through a Visual Analogue Scale
Time Frame: at 2 weeks before the implantation of the device (Day 0), Day 0, 1 week from Day 0, 2 weeks from Day 0, 1 month from Day 0, 3 months from Day 0 and 6 months from Day 0
|
Assess pain intensity with a Visual Analogue Scale (VAS) at each study visit.
The VAS measure will be made through a cross (X) that the patient has to put along a bar.
The left margin of the bar corresponds to "no pain" (0 score) and the right margin to "worst pain" (10 score).
|
at 2 weeks before the implantation of the device (Day 0), Day 0, 1 week from Day 0, 2 weeks from Day 0, 1 month from Day 0, 3 months from Day 0 and 6 months from Day 0
|
Measure of the Investigator's satisfaction on the implantation procedure, through a Visual Analogue Scale (VAS) and an ad-hoc questionnaire
Time Frame: implantation satisfaction (VAS + ad-hoc questionnaire) at the implantation of the device (Day 0) and REGENERA performance (VAS) at 6 months from Day 0
|
Assess investigator's satisfaction on the implantation procedure, through a Visual Analogue Scale (VAS) and an ad-hoc questionnaire (developed by the Sponsor), and on the REGENERA performance, through a VAS scale. The VAS measure will be made through a cross (X) that the patient has to put along a bar. The left margin of the bar corresponds to "no pain" (0 score) and the right margin to "worst pain" (10 score). The ad-hoc questionnaire has a unique scale made of 5 levels (1 corresponds to "strongly disagree" and 5 corresponds to "strongly agree") to be used for each question. As there are 12 questions, 12 is the minimum score and 60 is the maximum score as a sum of all answers. |
implantation satisfaction (VAS + ad-hoc questionnaire) at the implantation of the device (Day 0) and REGENERA performance (VAS) at 6 months from Day 0
|
Cumulative number of all Adverse Events associated with the surgical procedure
Time Frame: at 6 months from the implantation of the device
|
Cumulative number of all Adverse Events associated with the surgical procedure: number of re-operations and / or explants due to seroma, hematoma, infection, wound dehiscence, skin retraction, acute inflammatory reactions, allergic reactions to the device, persistent pain.
|
at 6 months from the implantation of the device
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Manuela Roncella, MD, Azienda Ospedaliero, Universitaria Pisana
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tens-BBC/001/2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Benign Breast Disease
-
Jose Ignacio SánchezWelwaze Medical Inc.Enrolling by invitationBreast Cancer | Benign Breast Disease | Breast DiseaseSpain
-
Brigham and Women's HospitalNational Cancer Institute (NCI)Active, not recruitingBenign Breast DiseaseUnited States
-
University of MichiganWayne State UniversityCompleted
-
National Cancer Institute (NCI)CompletedBenign Breast DiseaseUnited States
-
Zedsen LimitedImperial College Healthcare NHS TrustRecruitingBreast Cancer | Benign Breast DiseaseUnited Kingdom
-
Assistance Publique - Hôpitaux de ParisInstitut PasteurCompleted
-
Brigham and Women's HospitalBreast Cancer Research Foundation; Partners in Health; Rwanda Biomedical CentreCompletedBreast Cancer | Benign Breast DiseaseRwanda
-
Alexandria UniversityCompletedBenign Breast Disease | Duct Ectasia BreastEgypt
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Susan G. Komen Breast Cancer FoundationRecruitingBreast Cancer | Benign Breast DiseaseUnited States
-
Johnson & Johnson Medical, ChinaCompleted
Clinical Trials on REGENERA
-
Tensive SRLRecruitingBreast Neoplasm Malignant Female | Mastectomy, SegmentalItaly, Spain
-
Human Brain Wave S.r.l.Nextrasearch S.r.l.s.; Ibismed S.r.l.Not yet recruiting