Back to resultsREGENERA Implant in Excised Non-Malignant Breast Lesions
Primary Purpose
Benign Breast Disease
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
REGENERA
Sponsored by
About this trial
This is an interventional supportive care trial for Benign Breast Disease focused on measuring Lumpectomy, Bio-absorbable
Eligibility Criteria
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).
Sites / Locations
- Azienda Ospedaliero Universitaria Pisana
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm 1
Arm Description
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.
Outcomes
Primary Outcome Measures
Cumulative number of all Serious Adverse Events
Cumulative number of Serious Adverse Events collected throughout the study and associated with the REGENERA implant device (Adverse Device Effects)
Secondary Outcome Measures
Measurement of changes in breast appeareance before and after surgery through antropomorphic chest parameters
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.
Measurement of the reduction of reliability of the currently used diagnostic imaging techniques
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.
Patient Quality of Life measured through Breast-Q questionnaire
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).
Patient pain measurement through a Visual Analogue Scale
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).
Measure of the Investigator's satisfaction on the implantation procedure, through a Visual Analogue Scale (VAS) and an ad-hoc questionnaire
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.
Cumulative number of all Adverse Events associated with the surgical procedure
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04131972
Brief Title
REGENERA Implant in Excised Non-Malignant Breast Lesions
Official Title
A Pilot Study of REGENERA Implant in Localized Non- Malignant Breast Lesions Treated by Excision or Lumpectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 11, 2019 (Actual)
Primary Completion Date
November 27, 2021 (Actual)
Study Completion Date
November 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tensive SRL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Breast Disease
Keywords
Lumpectomy, Bio-absorbable
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm 1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
REGENERA
Intervention Description
REGENERA breast implant
Primary Outcome Measure Information:
Title
Cumulative number of all Serious Adverse Events
Description
Cumulative number of Serious Adverse Events collected throughout the study and associated with the REGENERA implant device (Adverse Device Effects)
Time Frame
at 6 months from implantion of the device
Secondary Outcome Measure Information:
Title
Measurement of changes in breast appeareance before and after surgery through antropomorphic chest parameters
Description
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.
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
Title
Measurement of the reduction of reliability of the currently used diagnostic imaging techniques
Description
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.
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
Title
Patient Quality of Life measured through Breast-Q questionnaire
Description
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).
Time Frame
at 1 month from the implantation of the device (Day 0), 6 months from Day 0 versus 2 weeks before Day 0
Title
Patient pain measurement through a Visual Analogue Scale
Description
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).
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
Title
Measure of the Investigator's satisfaction on the implantation procedure, through a Visual Analogue Scale (VAS) and an ad-hoc questionnaire
Description
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.
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
Title
Cumulative number of all Adverse Events associated with the surgical procedure
Description
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.
Time Frame
at 6 months from the implantation of the device
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuela Roncella, MD
Organizational Affiliation
Azienda Ospedaliero, Universitaria Pisana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
REGENERA Implant in Excised Non-Malignant Breast Lesions
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