Open-label,Single Site,Pilot Clinical Investigation to Assess Detectability and Sizing of Invasive Breast Cancers,Detectability of Benign Breast Lesions,Differentiation Between Malignant and Benign Breast Lesions Using Wavelia # 2
Phase: NA
Conditions: Breast Cancer
Sponsor: MVG Industries SAS

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 1 of 34 
CLINICAL INVESTIGATION PLAN (CIP) 
 
CIP Number: 
TP.102.17.22.PAR 
ClinicalTrials.gov ID: 
NCT05757427 
Title of CIP: 
An open-label, single site, pilot clinical investigation to 
assess the detectability and sizing of invasive breast 
cancers, the detectability of benign breast lesions, as well 
as the differentiation between malignant and benign breast 
lesions using the Wavelia#2 Microwave Breast Imaging 
system 
Clinical Investigation 
Sponsor/Funder: 
MVG Industries SAS,  
13 Rue du Zéphyr,  
Parc d’Activités de l’Océane,  
91140 Villejust, FRANCE 
 
 
 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 2 of 34 
 
Table of Contents 
LIST OF ABBREVIATIONS ..........................................................................................4 
SYNOPSIS ........................................................................................................................7 
1 
INTRODUCTION ......................................................................................10 
1.1 
Rationale for the Clinical Investigation ........................................................10 
2 
CLINICAL INVESTIGATION OBJECTIVES .......................................12 
3 
DESIGN OF THE CLINICAL INVESTIGATION .................................13 
4 
SELECTION OF STUDY POPULATION ...............................................14 
4.1 
Overall Description of Trial Subjects ...........................................................14 
5 
CLINICAL INVESTIGATION PROCEDURES.....................................14 
6 
ADVERSE EVENTS, ADVERSE DEVICE EFFECTS, DEVICE 
DEFICIENCIES .........................................................................................18 
6.1 
Definitions ....................................................................................................18 
6.2 
Eliciting Adverse Events...............................................................................21 
6.3 
Evaluation of Adverse Events/Adverse Device Effects ................................21 
6.4 
Recording of Adverse Events in the CRF .....................................................25 
6.5 
Study Specific Reporting Procedure .............................................................25 
6.6 
Data Safety Monitoring Board (DSMB) Procedure .....................................27 
7 
STUDY ADMINISTRATION ....................................................................28 
7.1 
Informed Consent Process ............................................................................28 
7.2 
Regulatory Authority and Ethical Approval .................................................28 
7.3 
Study Organisation .......................................................................................29 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 3 of 34 
8 
SUSPENSION OR PREMATURE TERMINATION OF CLINICAL 
INVESTIGATION ......................................................................................33 
9 
FINANCING INSURANCE AND INDEMNITY ....................................33 
10 
REFERENCES ...........................................................................................33 
 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 4 of 34 
LIST OF ABBREVIATIONS 
Abbreviation or 
Term 
Definition/Explanation  
3D 
3 dimensional 
AAL 
Anterior Axillary Line 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
ASADE 
Anticipated Serious Adverse Device Effect 
BIRADS 
Breast Imaging Reporting and Database System 
BP line 
line perpendicular to the Anterior Axillary Line and passing 
from the nipple of the breast 
CI 
Confidence Interval 
CIP 
Clinical Investigation Plan  
C-N line 
line connecting the midpoint of the clavicle (C) and the nipple 
of the breast (N) 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CT 
Computerized Tomography 
DICOM 
Digital Imaging and Communications in Medicine 
EC 
Ethical Committee 
eCRF 
electronic Case Report Form 
EDC 
Electronic Data Capture 
EU 
European Union 
FiH 
First in Human 
FPI 
First Patient In 
GCP 
Good Clinical Practice 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 5 of 34 
GDPR 
General Data Protection Regulations 
GP 
General Practitioner 
HPRA 
Health Products Regulatory Authority 
IB 
Investigators Brochure 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
ICNIRP 
International 
Commission 
on 
Non-Ionizing 
Radiation 
Protection 
ID 
Identifier 
IDC 
Invasive Ductal Carcinoma 
IEC 
Independent 
Ethical 
Committee 
and 
International 
Electrotechnical Commission 
ILC 
Invasive Lobular Carcinoma 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
IVDR 
In Vitro Diagnostic Regulation 
LPLV 
Last Patient Last Visit 
MWBI 
Microwave Breast Imaging 
MDCG 
Medical Device Coordination Group 
MDR 
Medical Device Regulation 
MRI 
Magnetic Resonance Imaging 
MVG 
Microwave Vision Group Industries 
NB 
Naïve Bayesian 
NCA 
National Competent Authority 
OBCD 
Optical Breast Contour Detection 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 6 of 34 
PDF 
Portable Document Format 
PI 
Principal Investigator 
PIL 
Patient Information Leaflet 
REC 
Research Ethics Committee 
RF 
Radio-Frequency 
RMF 
Risk Management File 
ROI 
Region-Of-Interest 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAR 
Specific Absorption Rate 
SAS 
Statistical Analysis System 
SOP 
Standard Operating Procedure 
TL 
Transition Liquid 
TMF 
Trial Master File 
UAT 
User Acceptance Testing 
USADE 
Unanticipated Serious Adverse Device Effect 
VBD 
Volumetric Breast Density 
VDG 
Volpara Density Grade 
VDM 
Volumetric Density Measurement 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 7 of 34 
SYNOPSIS 
Short Title of Clinical 
Investigation 
An open-label, single site, pilot clinical investigation to assess 
the detectability and sizing of invasive breast cancers, the 
detectability of benign breast lesions, as well as the 
differentiation between malignant and benign breast lesions 
using the Wavelia#2 Microwave Breast Imaging system 
Name of 
sponsor/company 
MVG Industries SAS,  
13 Rue du Zéphyr,  
Parc d’Activités de l’Océane,  
91140 Villejust, FRANCE 
Stage of development 
Stage 2 – Preliminary Technical/Analytical Performance in 
accordance with the Guidance on Clinical Evaluation (MDR) / 
Performance Evaluation (IVDR) of Medical Device Software 
(MDCG 2020-1). 
Clinical Investigation 
Design/population 
The study is designed as a single arm two-stage adaptive trial 
following Simon’s two-stage design. Female patients who 
present to the symptomatic clinics with a breast abnormality will 
be reviewed for suitability and assessed for participation.  
Study Objectives 
The objectives of the clinical investigation are to assess the 
detectability and sizing of invasive breast cancers, the 
detectability of benign breast lesions, as well as the 
differentiation between malignant and benign breast lesions 
using the Wavelia#2 Microwave Breast Imaging System. 
Key inclusion and 
exclusion criteria 
Inclusion Criteria 
Female subjects attending the symptomatic breast units with an 
investigator assessed discrete breast abnormality of size 
>1cm who: 
• Have provided personal explicit written informed consent 
prior to any study related procedures. 
• Are 18 years or older. 
• Are able and willing to comply with the requirements of 
this study protocol.  

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 8 of 34 
• Have investigator confirmed intact breast skin (i.e., 
without bleeding lesion, no evidence of inflammation, 
oedema and/or erythema of the breast).  
• Subjects whose breast size is adapted to the cylindrical 
container of the MWBI system.  
Exclusion Criteria 
To be eligible for inclusion in this study the subjects must NOT 
meet any of the following criteria: 
Female subjects who: 
• Have a cup size of A or whose breast is deemed too small 
to allow MWBI assessment in the opinion of the 
investigator. 
• Are pregnant or breast-feeding.  
• Have had surgery on either breast within the past 12 
months. 
• Have any aesthetic breast implant.  
• Have any active or metallic implant (e.g., cardiac 
pacemaker, stents, internal cardiac defibrillator, cardiac 
resynchronisation device, nerve stimulator, etc.), or 
subjects bearing any non-removable metallic object (e.g., 
piercing) on their torso. 
• Have significant co-morbidities or medical conditions 
which, in the opinion of the investigator, may cause 
unacceptable risk to the patient or compromise the 
integrity of the data.  
• Would be unsuitable for an MWBI scan or unlikely to 
follow the protocol in the opinion of the Investigator. 
Study Endpoints 
Primary Endpoints 
- 
Detectability rate – defined as the percentage of breast 
lesions (benign or malignant) that were detected by the 
Wavelia#2 Microwave Breast Imaging System 
- 
Discrimination between malignant and benign breast 
lesions 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 9 of 34 
Secondary Endpoints 
- 
Correct sizing of invasive breast cancers 
- 
Discrimination among different cancer types 
Number of subjects 
scanned 
73 
 
 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 10 of 34 
1 INTRODUCTION 
1.1 Rationale for the Clinical Investigation 
Microwave breast imaging (MWBI) has been investigated as a novel modality for the detection 
of breast disease, offering a non-ionising, non-compressive approach [1] and as a potential 
diagnostic management strategy in the monitoring of neoadjuvant chemotherapy [2]. Despite 
extensive efforts to harness the potential of this modality, spanning 40 years, a pertinent clinical 
application for this modality has yet to be identified [3,4] 
To date, a total of ten (10) MWBI system prototypes have been employed in human subject 
tests, to investigate the clinical utility of MWBI [3,5,6]. While some studies to date have been 
too small to determine clinical efficacy, larger-scale trials have been conducted with three (3) 
state-of-the-art MWBI system prototypes, with favourable preliminary results [7-9]. Despite 
encouraging clinical results being reported, several recurrent limitations, detailed in Table 1 
remain unresolved across most studies, likely hindering the translation of this modality to the 
clinical setting. 
Table 1: Current unresolved limitations of the MWBI technology  
A non-negligible false positive rate. 
The challenges of managing a wide range of breast sizes with the same MWBI system. 
The automated and repeatable/consistent detection of breast pathologies of various types in 
breasts of various levels of density. 
Factor analysis (breast density, breast size, age, cancer size, histological subtype and stage) 
in the absence of consistent datasets from larger-scale MWBI clinical trials 
The identification of clinical cases where the addition of MWBI would be a useful clinical 
adjunct to detect or characterise breast pathology.  
The detectability of small, non-palpable, breast pathologies. 
The achievable accuracy of lesion localization in the breast has not been quantified with 
MWBI by any group. 
The standardization of the patient positioning and scan process. 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 11 of 34 
The above listed challenges justify further clinical research with alternative MWBI systems, 
such as Wavelia.  
In the First-in-Human (FiH) study, conducted in 25 patients, the Wavelia#1 prototype system 
demonstrated the ability to detect and discriminate between palpable breast lumps, the imaging 
procedure had no safety issues and patients reported a favourable experience of the MWBI scan. 
The promising findings from this study, which provided initial data to support a valid clinical 
association in accordance with Stage 1 of the Guidance on Clinical Evaluation (MDR) / 
Performance Evaluation (IVDR) of Medical Device Software (MDCG 2020-1), have warranted 
the preparation of further clinical investigations with an upgraded prototype version of the 
Wavelia system (Wavelia#2). 
The clinical data that will be collected in this 2nd study with Wavelia is intended to build upon 
the outcomes of the First in Human (FiH) study (TN.32.1.17. SATF), as reported in [10], as 
well as further address the current limitations of the state-of-the-art MWBI technology applied 
to clinical trials by now, as listed in Table 1 above. 
Considering the notable number of technical adaptations of the Wavelia MWBI system, a multi-
stage adaptive design will be implemented in this clinical study, allowing to first assess the 
technical performance of the upgraded Wavelia#2 MWBI prototype on a small patient dataset.  
Rationale / Specification for the Technical Go/No-Go 
In the case of a technical No-Go at the end of Stage 1 of the study, modification/correction of 
the Wavelia#2 prototype will be assessed by MVG, to be followed by a repeat of Stage 1 and 
requiring a second technical Go/No-Go evaluation, before proceeding to Stage 2. The following 
aspects will be required: 
• Any action required to address technical modification(s) must be performed by the 
MVG engineering team, directly at the clinical investigation site (i.e. without need to 
transfer the prototype back to the MVG factory in France).  
• A maximal duration of 1 month of pause of the study, for the technical intervention to 
be implemented and tested, will be considered.  
• A maximum of two Technical Go/No-Go assessments can be performed. 
If any of the above criteria are not met at initial MVG and clinical investigator assessment, it 
will be considered as requiring a study termination by MVG.  

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 12 of 34 
If all of the above criteria are met the proposed modifications/corrections to be made to the 
device will be specified and justified by MVG in an amendment to be submitted to the HPRA 
for review and approval prior to implementation. 
Lesion detectability assessment for the Technical Go/No-Go evaluation 
Given the early phase of development of Wavelia and the lack of standardization of the lesion 
detection process, in the context of the technical go/no-go evaluation, the detectability of the 
dominant discrete lesion from a given MWBI scan dataset will be qualitatively assessed.   
A review by independent radiologists who are not engaged in the study will be implemented as 
part of the final data analysis. 
The potential benefit of the device is to avoid exposing the patient to ionizing radiation. Having 
both MWBI and standard of care reference images may benefit subjects by improving 
identification of suspicious findings. A benefit, however, cannot be guaranteed. 
2 CLINICAL INVESTIGATION OBJECTIVES 
Primary study objectives: 
▪ Primary Objective #1: Assess the detectability rate of malignant and benign breast 
lesions. This analysis can be completed per cancer type if sufficient data is available.  
▪ Primary Objective #2: Assess the potential for differentiation between malignant and 
benign breast lesions, using Wavelia MWBI. 
Secondary study objectives: 
▪ Secondary Objective #1: Assess the lesion sizing for patients who have undergone 
surgery post MWBI scan and for whom post-surgery histology data is available. 
▪ Secondary Objective #2: Assess the potential for differentiation between ILC and IDC 
cancer types, or other cancer types (if sufficient data is available) using Wavelia MWBI. 
Exploratory Objective: evaluate the Wavelia MWBI breast lesion detectability rate (either 
malignant or benign) on patients with no biopsy clip, marking the lesion position in the breast. 
Safety objective: provide further data to support the establishment of the safety profile of the 
investigational medical imaging device and associated procedures.  

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 13 of 34 
3 DESIGN OF THE CLINICAL INVESTIGATION 
This second clinical investigation of the Wavelia MWBI modality, is intended to progress to 
Stage 2 of MDCG 2020-1 in an adaptive manner. 
The adaptive method for clinical investigation design is described below. 
▪ Step #1: Preliminary Technical Performance Assessment / Interim Data Analysis 
Clinical data collection on an initial 30 patients with a dominant discrete lesion attributed 
to aggregates 1 and 2 for verification and approval of the technical evolutions that have 
been integrated in the Wavelia#2 prototype with a decision on a Technical Go/No-Go. 
Offline MWBI data processing will be performed by MVG, to form the images and extract 
the features for clinical analysis with access to reference clinical data provided, per patient 
case. In the case of a technical No-Go after an initial 30 patients a maximum of one 
additional technical assessment will be conducted in a second 30 patients. 
o No-Go - Pilot #1 paused: Prototype adaptation followed by a second and final 
technical re-evaluation will be performed as described above.  
o Go - Continue clinical data collection.  
▪ Step #2: Build up on the clinical findings of the FiH study   
If the technical status of the Wavelia#2 device is verified, continue to gather clinical data 
from an additional 32 patients for a clinical and technical assessment of Wavelia# 2, to build 
upon the findings of the FiH clinical investigation.  
Offline MWBI data processing will be performed by MVG, to form the images and extract 
the features for clinical analysis with access to reference clinical data provided, per patient 
case.  
The sample sizes have been formally computed, based on Simon’s 2-stage adaptive study 
design. 
▪ Final Data Analysis 
The final data analysis will include all patients who have received an MWBI scan for the 
safety analysis. The full clinical and technical analysis will be performed on all patients 
who have been scanned with the technically validated MWBI to build upon the findings of 
the previous, FiH, study of Wavelia. The patient groups and clinical features of interest will 
be determined by the clinical and technical team based on the clinical and technical 
assessments of the datasets from all patients. 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 14 of 34 
Ongoing data reviews are planned to be performed with the clinical and radiology site 
investigators for every 15 patients, all along the study.  
A schematic description of the adaptive study design is provided in the Figure 1 below: 
Figure 1: Schematic description of the adaptative study design 
4 SELECTION OF STUDY POPULATION 
4.1 Overall Description of Trial Subjects 
Patients will be approached for inclusion in this clinical investigation from a single site 
University Hospital Galway. The study will be introduced to patients presenting to the 
symptomatic breast unit with a breast abnormality. 
5 CLINICAL INVESTIGATION PROCEDURES 
All patients with an investigator assessed discrete breast abnormality of size >1cm and who are 
called to attend the symptomatic breast unit for assessment as per standard of care protocol will 
be considered for participation in this clinical investigation.  
 
Clinical and Technical 
Performance assessment
Build upon the findings of the 
FiH study
Reference Clinical Data a priori 
provided, per patient
Preliminary Technical 
Performance assessment
Verify and validate the 
technical evolutions that 
have been integrated in the 
Wavelia # 2 prototype 
Reference Clinical Data a priori 
provided, per patient
Go / No-
Go
Interim review 
with the 
clinicians every 
15 patients
Interim review 
with the 
clinicians every 
15 patients
Study Paused:
Prototype 
adaptation
Go
No-Go*
Stage 1: 
n1 = 30 patients
Stage 2: 
n2 = 32 patients
Final Data Analysis
on Total sample size of
N = 62
Evaluable patients
Cumulative Data Review 
with the clinicians
Define clinical features
for final analysis
* Early stopping for futility after the first stage, if less than 18 of the 30 breast lesions are detectable
Simon’s 2-stage adaptive design

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 15 of 34 
Consenting Process: 
Potentially suitable patients, presenting with a discrete breast abnormality at the symptomatic 
breast unit will be invited to discuss the study and any study procedures in detail. The Patient 
Information leaflet will also be provided to the patient. 
After having sufficient time to read and understand all information provided, patients who 
confirm interest in participation and are willing to participate will be asked to provide written 
informed consent by the research nurse prior to any study activities taking place.  
If eligibility is confirmed the patient will be enrolled into the study and will be scheduled for 
an MWBI scan either before or after standard of care assessments (See Table 2 and Table 3). 
Table 2: Schedule of events for patients having MWBI on the day of presentation to the 
symptomatic breast unit 
Procedures 
†Visit 1 
∞Telephone 
Safety 
Assessment 
αOn-Site 
Safety 
Follow-up 
Visit 
§End of Study 
FU Visit  
Written informed consent 
X 
 
 
 
Demographics 
X 
 
 
 
Medical History  
X 
 
 
 
Targeted Physical examination 
X 
 
 
 
Confirmation of Inclusion/Exclusion 
Criteria 
X 
 
 
 
Urine Pregnancy Test  
(prior to MWBI procedure, on day of 
MWBI scan) 
X+ 
 
 
 
Enrolment 
X 
 
 
 
Microwave Breast Investigation 
including patient breast marking 
procedure, as defined in Appendix A 
(OBCD scan and MWBI scan) 
X 
 
 
 
Patient Experience Questionnaire 
X 
 
 
 
Adverse Event Review 
X 
∞X 
αX 
X 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 16 of 34 
Procedures 
†Visit 1 
∞Telephone 
Safety 
Assessment 
αOn-Site 
Safety 
Follow-up 
Visit 
§End of Study 
FU Visit  
On-Site Safety Clinical Breast / Skin 
Assessment 
 
∞X 
αX 
 
End of Study Follow-up Patient 
Clinical Breast / Skin Assessment 
 
 
 
§X 
Adverse Event Review will only occur once the patient is consented  
† On the day of presentation to symptomatic breast unit assessment clinic 
+ Urine Pregnancy test to be conducted on the day of the MWBI scan, prior to the scan 
procedure (if patient is of childbearing potential) 
∞ 24 to 72 hours post MWBI Telephone Safety Assessment – Breast Skin Questionnaire 
and Adverse Event check  
α On-Site Safety Follow-up Visit will be performed as soon as possible only for patients 
who report breast/skin abnormalities or adverse events at the Telephone Safety 
Assessment 
§ Up to 21 days post MWBI, or before surgery, whichever occurs first. 
 
Table 3: Schedule of events for patients having MWBI AFTER standard of care 
assessments 
Procedures 
†Visit 1 
‡Visit 2 
±Telephone 
Safety 
Assessment 
αOn-Site 
Safety 
Follow-
up Visit 
§End of 
Study 
FU Visit 
Written informed consent 
X 
 
 
 
 
Demographics 
X 
 
 
 
 
Medical History  
X 
X 
 
 
 
Targeted Physical examination 
X 
X 
 
 
 
Confirmation of Inclusion/Exclusion 
Criteria 
X 
X 
 
 
 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 17 of 34 
Procedures 
†Visit 1 
‡Visit 2 
±Telephone 
Safety 
Assessment 
αOn-Site 
Safety 
Follow-
up Visit 
§End of 
Study 
FU Visit 
Urine Pregnancy Test  
(prior to MWBI procedure, on day 
of MWBI scan) 
 
X+ 
 
 
 
Enrolment 
 
X 
 
 
 
Microwave Breast Investigation 
including patient breast marking 
procedure, as defined in Appendix A 
(OBCD scan and MWBI scan) 
 
X 
 
 
 
Patient Experience Questionnaire 
 
X 
 
 
 
Adverse Event Review 
 
X 
∞X 
αX 
X 
On-Site Safety Clinical Breast / Skin 
Assessment 
 
 
∞X 
αX 
 
End of Study Follow-up Patient 
Clinical Breast / Skin Assessment 
 
 
 
 
§X 
Adverse Event Review will only occur once the patient is consented. 
† On the day the patient receives their biopsy results or at a subsequent scheduled visit before 
treatment 
+ Urine Pregnancy test to be conducted on the day of the MWBI scan, prior to scan procedure 
(if patient is of childbearing potential) 
‡ ≥14 days (not including day of biopsy) post biopsy and ≤ 12 weeks post standard of care 
reference imaging 
∞ 24 to 72 hours post MWBI Telephone Safety Assessment – Breast Skin Questionnaire and 
Adverse Event check  
α On Site Safety Follow-up Visit will be performed as soon as possible only for patients who 
report breast/skin abnormalities or adverse events at the Telephone Safety Assessment 
§ Up to 21 days post MWBI, or before surgery, whichever occurs first.  
Standard of Care Data/Reference Imaging: 
In this clinical investigation, the MWBI scan will not be used for patient diagnosis and will be 
conducted in addition to standard of care assessments. Standard of care assessments performed 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 18 of 34 
by the physician, as per normal practice in the symptomatic breast unit of University Hospital 
Galway include: 
• Conventional medical history 
• Clinical assessment, breast examinations and standard of care reference imaging (e.g. 
Mammogram and / or Ultrasound/and or MRI/and/or CT scan) 
• Biopsy (if applicable) 
The written radiology reports from standard of care reference imaging, as well as the core 
biopsy reports if applicable, will be acquired and used to evaluate the performance of the MWBI 
subsystem in terms of detecting and estimating size and consistency of the discrete breast 
abnormality. 
Relevant data from Multi-Disciplinary Team (MDT) meetings in relation to the therapeutic 
strategy for the patient and if surgery is planned will be obtained.  
In the case of patients who are scheduled for surgery, key reference data from their post-surgery 
histology report and post-surgery MDT meeting will also be collected for the evaluation of the 
MWBI imaging results in relation to the estimated tumour size. 
6 ADVERSE EVENTS, ADVERSE DEVICE EFFECTS, DEVICE 
DEFICIENCIES 
Adverse Event Review will only occur once the patient is consented and continues until the 
End of Study Follow Up Visit.  The End of Study Follow-up Visit will occur up to 21 days post 
MWBI or prior to surgery, whichever happens first.  
6.1 Definitions 
The following definitions have been sourced from the International Standard for Clinical 
investigation of medical devices for human subjects - Good clinical practice, ISO 
14155:2020(E), with the exception of 6.1.9 the definition for ‘reportable device deficiency’ 
which is sourced from the Medical device Coordination Group (MDCG) guidance document 
MDCG 2020-10/1 Rev 1 ‘Safety reporting in clinical investigations of medical devices under 
the Regulation (EU) 2017/745’, Oct 2022. 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 19 of 34 
6.1.1 Adverse Event (AE) 
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users or other persons, whether or not 
related to the investigational medical device and whether anticipated or unanticipated.  
This definition includes events related to the investigational medical device or the comparator. 
This definition includes events related to the procedures involved. For users or other persons, 
this definition is restricted to events related to the use of investigational medical devices or 
comparators. 
6.1.2 Adverse Device Effect (ADE) 
Adverse event related to the use of an investigational medical device. This definition includes 
adverse events resulting from insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation, or any malfunction of the investigational medical device. 
This definition includes any event resulting from use error or from intentional misuse of the 
investigational medical device.  
Use Error  
User action or lack of user action while using the medical device that leads to a different result 
than that intended by the manufacturer or expected by the user. Use error includes the inability 
of the user to complete a task. Use errors can result from a mismatch between the characteristics 
of the user, user interface, task or use environment. Users might be aware or unaware that a use 
error has occurred. An unexpected physiological response of the patient is not by itself 
considered a use error. A malfunction of a medical device that causes an unexpected result is 
not considered a use error. 
6.1.3 Serious Adverse Event (SAE)  
Adverse events that led to any of the following: 
• Death  
• serious deterioration in health of the subject, users, or other persons as defined by one 
or more of the following: 
o a life-threatening* illness or injury, or 
o a permanent impairment of a body structure or a body function including chronic 
diseases, or 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 20 of 34 
o in-patient hospitalization** or prolongation of existing hospitalization, or 
o medical or surgical intervention to prevent life threatening illness or injury, or 
permanent impairment to a body structure or a body function, 
• foetal distress, foetal death, a congenital abnormality, or birth defect including physical 
or mental impairment. 
* Life-threatening refers to an event in which the subject was at risk of death at the time of the 
event; it does not refer to an event which hypothetically might have caused death if it were more 
severe.  
** Planned hospitalization for a pre-existing condition, or a procedure required by the CIP 
without serious deterioration in health, is not considered a serious adverse event. 
6.1.4 Serious Adverse Device Effect (SADE)  
Adverse device effect that has resulted in any of the consequences characteristic of a serious 
adverse event. 
6.1.5 Unanticipated Serious Adverse Device Effect (USADE)  
Serious adverse device effect which by its nature, incidence, severity, or outcome has not been 
identified in the current risk assessment. 
6.1.6 Anticipated Serious Adverse Device Effect (ASADE) 
An Anticipated Serious Adverse Device Effect is defined as an effect which by its nature, 
incidence, severity or outcome has been identified in the risk assessment. 
6.1.7 Serious Health Threat  
Signal from any adverse event or device deficiency that indicates an imminent risk of death or 
a serious deterioration in the health in subjects, users or other persons, and that requires prompt 
remedial action for other subjects, users or other persons. This would include events that are of 
significant and unexpected nature such that they become alarming as a potential serious health 
hazard or possibility of multiple deaths occurring at short intervals. 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 21 of 34 
6.1.8 Device Deficiency  
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, 
usability, safety or performance. Device deficiencies include malfunctions, use errors, and 
inadequacy in the information supplied by the manufacturer including labelling. This definition 
includes device deficiencies related to the investigational medical device or the comparator. 
A device malfunction is defined as the failure of an investigational medical device to perform 
in accordance with its intended purpose when used in accordance with the instructions for use 
or CIP, or IB.  
6.1.9 Reportable Device Deficiency (as per MDCG 2020-10/1)  
A Device Deficiency is considered a reportable event if it might have led to a SAE if appropriate 
action had not been taken, intervention had not occurred, or circumstances had been less 
fortunate. 
6.2 Eliciting Adverse Events 
Comprehensive assessments of any adverse event experienced by the subject will be performed 
throughout the course of the study from the time of subject’s signature of informed consent. 
Study site personnel will report any adverse event, whether observed by the Investigator or 
reported by the subject. 
Data on adverse events will be obtained at scheduled or unscheduled study visits, based on 
information spontaneously provided by the subject and/or through non leading questioning of 
the subject. 
6.3 Evaluation of Adverse Events/Adverse Device Effects 
The investigator or delegate will report all AE’s/SAE’s/ADE’s/SADE’s/device deficiencies to 
the sponsor as outlined in Section 6.4. 
All safety reporting must be carried out in compliance with the current version of the Medical 
Device Coordination Group (MDCG) guidance document ‘Safety reporting in clinical 
investigations of medical devices under the Regulation (EU) 2017/745’and the International 
Standard for Clinical investigation of medical devices for human subjects - Good clinical 
practice, ISO 14155:2020(E). 
Assessment of Seriousness 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 22 of 34 
The investigator or appropriately qualified member of the site team should assess the 
seriousness of an event as per the SAE definition in the CIP. 
6.3.1 Assessment of Severity 
The investigator will assess the severity for each AE, ADE, SAE and SADE and record this on 
the CRF according to one of the following categories: 
Mild: An event that is easily tolerated by the subject, causing minimal discomfort, and not 
interfering with everyday activities. 
Moderate: An event that is sufficiently discomforting to interfere with normal everyday 
activities. 
Severe or medically important: An event that prevents normal everyday activities. 
Life threatening: An event that has life-threatening consequences. 
Note: the term ‘severe’, should not be confused with ‘serious’ which is a regulatory definition 
based on subject/event outcome or action criteria. 
6.3.2 Assessment of Causality 
All AEs will be evaluated by both the investigator and the sponsor to determine the causal 
relationship to the investigational medical device or procedures. 
The relationship between the use of the medical device (including the associated medical - 
surgical procedure) and the occurrence of each adverse event shall be assessed and categorized. 
During causality assessment activity, clinical judgement shall be used and the relevant 
documents containing the foreseeable serious adverse events and the potential risks are listed 
such as the Investigator’s Brochure, the Clinical Investigation Plan or the Risk Management 
File shall be consulted. The presence of confounding factors, such as concomitant 
medication/treatment, the natural history of the underlying disease, other concurrent illness or 
risk factors shall also be considered.  
For the purpose of harmonizing reports, each SAE will be classified according to four different 
levels of causality:  
(1) Not related (2) Possible (3) Probable (4) Causal relationship  

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 23 of 34 
The sponsor and the investigators will use the following definitions to assess the relationship 
of the serious adverse event to the investigational device, the comparator or the investigation 
procedure. 
Not related: relationship to the device or procedures can be excluded when: 
• the event has no temporal relationship with the use of the investigational device, or the 
procedures related to application of the investigational device; 
• the serious adverse event does not follow a known response pattern to the medical 
device (if the response pattern is previously known) and is biologically implausible; 
• the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible - and reintroduction of its use (or increase 
of the level of activation/exposure), do not impact on the serious adverse event; 
• the event involves a body-site or an organ that cannot be affected by the device or 
procedure; 
• the serious adverse event can be attributed to another cause (e.g. an underlying or 
concurrent illness/ clinical condition, an effect of another device, drug, treatment or 
other risk factors); 
• the event does not depend on a false result given by the investigational device used for 
diagnosis, when applicable; 
In order to establish the non-relatedness, not all the criteria listed above might be met at the 
same time, depending on the type of device/procedures and the serious adverse event. 
Possible: The relationship with the use of the investigational device or comparator, or the 
relationship with procedures, is weak but cannot be ruled out completely.  Alternative causes 
are also possible (e.g.  an underlying or concurrent illness/ clinical condition or/and an effect 
of another device, drug or treatment).  Cases where relatedness cannot be assessed, or no 
information has been obtained should also be classified as possible. 
Probable: The relationship with the use of the investigational device or comparator, or the 
relationship with procedures, seems relevant and/or the event cannot be reasonably explained 
by another cause. 
Causal relationship: the serious adverse event is associated with the investigational device, 
comparator or with procedures beyond reasonable doubt when:  

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 24 of 34 
• the event is a known side effect of the product category the device belongs to or of 
similar devices and procedures; the event has a temporal relationship with 
investigational device use/application or procedures; 
• the event involves a body-site or organ that 
o the investigational device or procedures are applied to; 
o the investigational device or procedures have an effect on; 
• the serious adverse event follows a known response pattern to the medical device (if the 
response pattern is previously known);  
• the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the serious adverse event (when clinically feasible);  
• other possible causes (e.g. an underlying or concurrent illness/ clinical condition or/and 
an effect of another device, drug or treatment) have been adequately ruled out; 
• harm to the subject is due to error in use; 
• the event depends on a false result given by the investigational device used for diagnosis, 
when applicable; 
In order to establish the relatedness, not all criteria listed above might be met at the same time, 
depending on the type of device/procedures and the serious event. 
Any AEs/SAEs judged as having a reasonable suspected causal relationship (e.g. possible, 
probable or causal relationship) to the investigational medical device or procedures will be 
classified as an ADE/SADE. 
6.3.3 Assessment of Expectedness 
A list of all foreseeable adverse events and anticipated adverse device effects, together with 
their likely incidence, mitigation, or treatment, have been included in the Risk Management 
File, after the completion of the Risk Analysis of the investigational medical imaging device.  
An expectedness assessment will be carried out by the Sponsor for each SADE according to 
the current versions of the risk management file. 
6.3.4 Exemptions from Safety Reporting  
The following event would be commonly experienced in this cohort of participants and is 
therefore exempt from safety reporting: 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 25 of 34 
i. 
Admission to hospital for surgery to the affected breast as part of their standard of care 
treatment 
However, if any additional seriousness criteria are met during this hospitalisation, they 
are subject to SAE reporting. 
6.4 Recording of Adverse Events in the CRF 
The investigator or delegate will record every Adverse Event (AE), Adverse Device Effect 
(ADE), Serious Adverse Event (SAE), Serious Adverse Device Effect (SADE) or observed 
device deficiency (DD) and report it to the sponsor together with an assessment. All AEs, ADEs, 
SAEs, SADEs and DDs will be reported to the Sponsor as per the timelines in Section 6.5 of 
the CIP. 
As the quality and precision of acquired AE data are critical, Investigators must use the adverse 
event definitions provided in Section 6.1 of the CIP.  
• Whenever possible, recognised medical terms should be used to describe AEs (for 
example, ‘influenza’ rather than ‘flu’), and abbreviations should be avoided. 
• AEs should be described using a specific clinical diagnosis, if this is available, rather 
than a list of component signs or symptoms (for example, ‘congestive heart failure’ 
rather than ‘dyspnoea, rales and cyanosis.’)  
• Signs and symptoms that are not linked (as "co-manifestations”) to an identified disease 
or syndrome, or for which an overall diagnosis is not available, should be reported as 
individual AEs in separate CRF AE page(s).  
• Provisional diagnosis (e.g., “suspected Myocardial Infarction”) are acceptable but 
should be followed up to a definite diagnosis, if finally available. 
6.5 Study Specific Reporting Procedure  
6.5.1 Reporting by the investigator to the Sponsor  
All AEs, ADEs and device deficiencies (that do not meet the definition of reportable device 
deficiencies) should be reported to the sponsor in a timely manner. 
In compliance with the current version of the Medical device Coordination Group (MDCG) 
guidance document ‘Safety reporting in clinical investigations of medical devices under the 
Regulation (EU) 2017/745’ and the ISO guidelines 14155:2020(E) all SAEs, SADEs and device 
deficiencies that meet the criteria of a reportable event will be fully recorded and reported to 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 26 of 34 
the Sponsor by the investigator immediately but no later than 3 calendar days after 
investigational site personnel’s awareness of the event. 
Site personnel are considered aware of an adverse event/DD from the time of first notification 
of the first member of the investigator site team, as per the site delegation log. All 
SAE’s/SADE’s and reportable device deficiencies will be submitted by site by completing the 
required fields on the AE/device deficiency CRF. A valid report must include all of the 
following: 
• Adverse event/device deficiency term (based on what is known at time of reporting) 
• Seriousness criteria (SAE form only) 
• Date of procedure/first use of investigational device 
• Date of event onset 
• Severity assessment (SAE form only) 
• Causality assessment (SAE form only) 
• Investigator signature 
The immediate report will be followed by detailed, written reports. The immediate and follow 
up reports will identify participants by unique code numbers. 
All SAE/reportable DD information must be recorded on a SAE/reportable DD form submitted 
to sponsor. Additional information received for an event (follow-up or corrections to the 
original event) should be detailed and submitted to the sponsor in an expedited manner and 
within 3 days of site awareness of additional information. The Site Investigator or delegate will 
follow AEs reported during participation in the trial until resolved, considered stable or 
completion of participation in the Clinical Investigation. Follow up information will be sought 
and submitted as it becomes available. All SAEs should be followed up until resolution or they 
are clearly determined to be due to a participants stable or chronic condition or intercurrent 
illness(es). 
If the eCRF is unavailable, a paper copy of the eCRF SAE/DD reporting form and supporting 
documentation 
(if 
applicable) 
should 
be 
completed 
and 
submitted 
to 
saereport@universityofgalway.ie within the required timelines for the event. Events submitted 
to the Sponsor in this manner should be entered in the eCRF as soon as it becomes available.  
6.5.2 Reporting to the National Competent Authority and Ethics Committee  
The sponsor will be responsible for the classification of the adverse events, after reviewing the 
principal investigator’s assessment. 
The Sponsor (or delegate) is responsible for the submission of reportable events to the NCA 
and Ethics Committee. The summary reporting form as provided in the current version of the 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 27 of 34 
MDCG guideline ‘Safety reporting in clinical investigations of medical devices under the 
Regulation (EU) 2017/745’, shall be filled in/updated for each reportable event. This will be 
submitted to the NCA and EC each time a new reportable event or new findings/updates in 
relation to already reported events are reported to the Sponsor (or delegate).    
Timelines for reporting to the NCA 
The sponsor must adhere to the following timelines in the submission of reportable events to 
the NCA: 
The sponsor (or delegate) must report to all NCAs where the clinical investigation is authorised 
to start: 
• For all reportable events which indicate an imminent risk of death, serious injury, or 
serious illness and that requires prompt remedial action for other patients/subjects, users 
or other persons or a new finding to it should be reported to the NCA immediately, but 
not later than 2 calendar days after awareness by sponsor of a new reportable event 
or of new information in relation to an already reported event. This includes events that 
are of significant and unexpected nature such that they become alarming as a potential 
public health hazard. It also includes the possibility of multiple deaths occurring at short 
intervals. 
• Any other reportable events or a new finding/update to it should be reported to the NCA 
immediately, but not later than 7 calendar days following the date of awareness by 
the sponsor of the new reportable event or of new information in relation to an already 
reported event. 
Timelines for reporting to the EC 
The sponsor (or delegate) must report to the EC where the clinical investigation is authorised 
to start: 
• For all reportable events, as soon as possible after first becoming aware of them. 
The sponsor (or delegate) will submit upon request a safety report to the NCA. 
The sponsor (or delegate) will submit annual safety reports to the EC, if required.  
6.6 Data Safety Monitoring Board (DSMB) Procedure  
A DSMB will not be utilised for this Clinical Investigation.  

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 28 of 34 
7 STUDY ADMINISTRATION 
7.1 Informed Consent Process 
Before a subject can participate in the study, he or she must give explicit written informed 
consent. The informed consent process will be in accordance with ICH GCP, the Declaration of 
Helsinki and local regulatory requirements. Informed Consent Forms must be signed and 
personally dated by the subject and the research nurse who conducted the informed consent 
discussion. 
Prior to any study-related screening procedures being performed on the subject, the informed 
consent statement will be reviewed, signed and dated by the subject, and by the site team 
member who administered the informed consent process. A copy of the informed consent form 
will be given to the subject. The informed consent process will be clearly documented in the 
participant notes as per the requirements of ICH-GCP, ISO 14155 and MDR. No participant 
will be enrolled without signing the informed consent.  
Any new information or protocol amendment that substantially alters the scientific validity of 
the study or affects the subjects’ rights, safety, welfare, or their willingness to continue 
participation in the study, will result in the re-consenting of currently active patients on an 
updated and approved (as required by local law and regulation) patient information sheet and 
consent form. 
7.2 Regulatory Authority and Ethical Approval  
Before the study is initiated at a site, the Sponsor (or its delegate) will obtain approval to 
conduct the study from the appropriate regulatory authority in accordance with any applicable 
country-specific regulatory requirements. 
The sponsor will submit and obtain approval from the above parties for substantial amendments 
to the original approved documents. 
Before initiation of the study at a given centre, written approval of the protocol, Informed 
Consent Form and any information presented to potential subjects must be obtained from the 
appropriate Institutional Review Board or Independent Ethics Committee. If any amendments 
to any of these documents occur during the study, notification or written approval, as 
appropriate, must be obtained prior to their implementation.  
Where required by local regulations, the Sponsor (or its delegate) is responsible for ensuring 
IRB/IEC approval of the study.  

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 29 of 34 
7.3 Study Organisation 
7.3.1 Data Management 
The sponsor or designee is responsible for the data management of this study including 
assurance of data integrity. 
The Investigator or designee will be responsible for the study data in the electronic CRF 
provided by the Sponsor. It is the Investigator’s responsibility to ensure the accuracy of the data 
entered in the CRFs. Prior to the start of the study, the Investigator will complete a delegation 
log which will record the signature and initials of all persons in charge of eCRF completion. 
Each person involved in eCRF completion, review, correction and/or validation will be trained 
and then will have an individual login and access code to the eCRF. An eCRF user guide will 
be available for investigators/on-site personnel involved in eCRF completion including the 
CRA who is reviewing the eCRF data as well as vigilance officers and the medical monitor(s). 
All data must be electronically submitted and signed by the responsible investigator or one of 
his/her authorized staff members. 
The data will be entered into a validated EDC system compliant with the 21CFR part 11 and 
ICH-GCP guidelines. Only authorised personnel will have access to the EDC system. For each 
enrolled participant, an eCRF record will be maintained. eCRFs must be kept current to reflect 
participant status at each phase during the course of the investigation. The EDC system will 
keep track of all user actions via an audit trail functionality. The configuration of EDC and any 
study-specific implementation will be subject to internal User Acceptance Testing (UAT) before 
go-live for data entry. 
eCRF entries must be completed by appropriately trained site staff only. A log of trained and 
authorised staff able to complete the eCRF will be maintained by data management. 
The data and imaging material obtained in this study will be pseudonymized. Participants will 
be identified by a unique, EDC-generated patient ID. Any clinical report or medical image will 
be de-identified by the Investigator before submission onto participant's electronic record. The 
subject identification log, linking the identifiers to the participant’s name, will be kept in the 
site’s regulatory binder. This log will allow proper monitoring of the clinical records and by the 
appointed monitors in order to assure completeness, accuracy and correctness of the data 
collected at site. 
During trial conduct, data will be reviewed to verify the completeness, consistency, plausibility 
and relevance of the data in accordance with the approved Data Validation Plan. In the event 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 30 of 34 
that inconsistent data is captured, queries may be issued electronically to the site and answered 
electronically by that site personnel. 
Database lock will occur once quality assurance procedures have been completed. The database 
will not be locked before all data clarifications have been resolved and monitored and the 
decision on subject evaluation has been completed. PDF files of the electronic CRFs will be 
sent to the Investigator at the completion of the study.  Further details of the data management 
procedures will be included in the approved Data Management Plan.  
7.3.2 Study Monitoring 
Participating sites will be monitored to ensure compliance with the trial protocol, adherence to 
applicable regulations, accuracy of trial data and to ensure the safety and well-being of the 
subjects is preserved. 
The Investigator must ensure that CRFs are completed in a timely manner and must allow a 
Sponsor representative (CRA or study monitor) periodic access to CRFs, subject records and 
all study-related materials. Trial data submitted will be reviewed against subject charts and 
other sources containing original records of subject data. Source document verification will 
occur as detailed in the Monitoring Plan. 
The monitoring requirements for this this trial are detailed in the current version of the 
Monitoring Plan. The frequency of monitoring visits will be determined on a risk based 
approach taking into consideration factors such as the design of the study, the frequency of 
subject visits and the site enrollment rate. In order to verify that the study is conducted in 
accordance with ICH GCP, regulatory requirements, and the study protocol and that the data 
are authentic, accurate and complete, the study monitor will review CRFs and other study 
documents and will conduct source data verification.  
On-site monitoring visits will be conducted in accordance with the clinical investigation 
Monitoring Plan. On-site monitoring will be an ongoing activity from the time of initiation until 
clinical investigation close-out and will comply with the principles of GCP, ISO 14155 and 
MDR. The frequency and type of monitoring will be detailed in the Monitoring Plan and agreed 
by the trial Sponsor. 
Before the clinical investigation commences a Site initiation visit will take place to ensure that 
all relevant essential documents and supplies are in place and that site staff are fully aware of 
the clinical investigation protocol and procedures. On site monitoring visits during the clinical 
investigation will check the consenting procedures, completeness of patient records, the 
accuracy of entries in the CRFs, the adherence to the protocol, procedures and GCP, and the 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 31 of 34 
progress of patient recruitment. Monitoring will also ensure that the investigational device and 
Transition Liquid is being stored and maintained according to specifications. 
Monitoring activities will be documented in a monitoring report and will include a summary of 
items the monitor reviewed and observations regarding the completion of previous action items, 
significant findings, facts, deviations, conclusions, and recommended actions to be taken to 
secure compliance. 
The Principal Investigator will ensure that access to all investigation related documents 
including source documents (to confirm their consistency with CRF entries) are available 
during monitoring visits.  
Upon study completion, the Sponsor CRA or monitor will conduct a Site Closeout visit as 
outlined in the Monitoring Plan. This will involve collection of any outstanding documentation 
and resolution of all outstanding issues. 
7.3.3 Subject Confidentiality 
All information and data sent to parties involved in trial conduct concerning subjects or their 
participation in this trial will be considered confidential. The Investigator and the CRA 
(monitor) representing the Sponsor must ensure that the subjects’ anonymity is maintained. All 
participant identifiers must be redacted from all documentation prior to submission to the 
Sponsor. Data reported on the CRF that are derived from source documents must be consistent 
with the source documents or the discrepancies must be explained. 
All documents will be stored safely in a confidential and secure environment. On all study-
specific documents other than the signed consent, the subject will be referred to by the study 
subject identification number/code. 
The data will be stored in encrypted software only accessible to those directly involved in the 
study. Subjects will be identified by a study specific subject number and/or code in the database. 
The name and any other identifying detail will not be included in any study data electronic file. 
The Investigator will keep a separate log of subjects’ identification numbers, names, addresses, 
telephone numbers and hospital numbers (if applicable). Documents which will not be 
submitted to the Sponsor, such as signed Informed Consent Forms, should be maintained in 
strict confidence by the Investigator. 
The study will comply with the Data Protection Act and the General Data Protection 
Regulations (GDPR).  

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 32 of 34 
7.3.4 Direct Access to Source Data/Study Documentation 
The agreement with the Principal Investigator will include permission for investigation related 
monitoring, audits and regulatory inspections, by providing direct access to source data and 
investigation related documentation. Consent from patients for direct access to data by sponsor 
or sponsor representatives, auditors and regulatory inspectors will also be obtained. The patients’ 
confidentiality will be maintained and will not be made publicly available to the extent 
permitted by the applicable laws and regulations. 
Source documents for this study may include hospital records e.g.  procedure reports, imaging 
reports and data collection forms. These documents may be used to enter data on the case report 
form (CRF).  
7.3.5 Quality Assurance 
In compliance with ICH GCP and regulatory requirements, the Sponsor, a third party acting on 
behalf of the Sponsor, regulatory agencies or IRB/IECs may conduct quality assurance audits 
at any time during or following a study. The Investigator must agree to allow auditors and 
regulatory inspectors direct access to all study-related documents including source documents 
and must agree to allocate his or her time and the time of his or her study staff to the auditors 
in order to discuss findings and issues. 
In addition to the monitoring activities noted in 7.3.2, a quality management plan will be 
implemented by MVG which will include the establishment of metrics to be reported and 
reviewed at regular teleconferences with the Study Coordination  team throughout the study e.g. 
protocol and device issues, adverse events, monitoring findings, deviations from protocol and 
agreed study procedures to ensure any remedial action is taken in a timely fashion and to ensure 
appropriate reporting in accordance with regulated requirements. 
7.3.6 Retention of Essential Study Documents 
The sponsor and principal investigator shall maintain the clinical investigation documents. 
They shall take measures to prevent accidental or premature destruction of these documents. 
The principal investigator or sponsor may transfer custody of records to another person/party 
and document the transfer at the investigation site or at the sponsor's facility. 
Essential documents as defined by ICH GCP include the signed protocol and any amendment(s), 
copies of the completed CRFs, signed Informed Consent Forms from all subjects who 
consented, hospital records, diary cards and other source documents, IRB/IEC approvals and 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 33 of 34 
all related correspondence including approved documents, device accountability records, study 
correspondence and a list of the subjects’ names and addresses.  
The Investigator must retain copies of the essential documents for the period specified by ICH 
GCP and by applicable regulatory requirements. 
Essential documents will be retained for 25 years. The documents may be retained for a longer 
period if requested by the Sponsor.  
The Investigator will inform the Sponsor of the storage location of the essential documents and 
must contact the Sponsor for approval before destruction of any documents related to the study. 
The Investigator should take measures to prevent accidental or premature destruction of these 
documents. 
8 SUSPENSION OR PREMATURE TERMINATION OF CLINICAL 
INVESTIGATION 
The Sponsor may temporarily or permanently discontinue the study for safety, ethical, 
compliance or other reasons. If this is necessary, the Sponsor will endeavour to provide advance 
notification to the site. If the site or study is suspended or discontinued, the Investigator will be 
responsible for promptly informing the IRB/IEC.  
Where required by local regulations, the Sponsor (or delegate) will be responsible for informing 
the IRB/IEC of study or site discontinuation. 
In such cases, all study data and the Investigational Device must be returned to the Sponsor. 
9 FINANCING INSURANCE AND INDEMNITY 
MVG holds Public Liability (‘negligent harm’) and Clinical Trial (‘non-negligent harm’) 
insurance policies which apply to this trial. MVG is funding this trial. 
10 REFERENCES 
[1] 
A.W. Preece, I. Craddock, M. Shere, L. Jones, H.L. Winton, MARIA M4: clinical 
evaluation of a prototype ultrawideband radar scanner for breast cancer detection, J. 
Med. Imaging. (2016). doi:10.1117/1.JMI.3.3.033502. 

TP.102.17.22.PAR, WAVELIA#2 – PILOT #1        04 JUNE 2024 
Page 34 of 34 
[2] 
P.M. Meaney, P. a Kaufman, L.S. Muffly, M. Click, S.P. Poplack, W. a Wells, G.N. 
Schwartz, R.M. di Florio-Alexander, T.D. Tosteson, Z. Li, S.D. Geimer, M.W. Fanning, 
T. Zhou, N.R. Epstein, K.D. Paulsen, Microwave imaging for neoadjuvant 
chemotherapy monitoring: initial clinical experience., Breast Cancer Res. (2013). 
doi:10.1186/bcr3418. 
[3] 
D. O’Loughlin, M. O’Halloran, B.M. Moloney, M. Glavin, E. Jones, M.A. Elahi, 
Microwave breast imaging: Clinical advances and remaining challenges, IEEE Trans. 
Biomed. Eng. 65 (2018) 2580–2590. doi:10.1109/TBME.2018.2809541. 
[4] 
S. Kwon, S. Lee, Recent Advances in Microwave Imaging for Breast Cancer Detection, 
Int. J. Biomed. Imaging. (2016). doi:10.1155/2016/5054912. 
[5] 
B.M. Moloney, D. O’Loughlin, S.A. Elwahab, M.J. Kerin, Breast cancer detection—a 
synopsis of conventional modalities and the potential role of microwave imaging, 
Diagnostics. 10 (2020). doi:10.3390/diagnostics10020103. 
[6] 
R. Benny, T.A. Anjit, P. Mythili, An overview of microwave imaging for breast tumor 
detection, Prog. Electromagn. Res. B. 87 (2020) 61–91. doi:10.2528/PIERB20012402. 
[7] 
M. Shere, I. Lyburn, R. Sidebottom, H. Massey, C. Gillett, L. Jones, MARIA®M5: A 
multicentre clinical study to evaluate the ability of the Micrima radio-wave radar breast 
imaging system (MARIA®) to detect lesions in the symptomatic breast, Eur. J. Radiol. 
116 (2019) 61–67. doi:10.1016/j.ejrad.2019.04.017. 
[8] 
L. Sani, N. Ghavami, A. Vispa, M. Paoli, G. Raspa, M. Ghavami, F. Sacchetti, E. 
Vannini, S. Ercolani, A. Saracini, M. Duranti, G. Tiberi, Novel microwave apparatus 
for breast lesions detection: Preliminary clinical results, Biomed. Signal Process. 
Control. (2019). doi:10.1016/j.bspc.2019.04.025. 
[9] 
A. Janjic, M. Cayoren, I. Akduman, T. Yilmaz, E. Onemli, O. Bugdayci, M.E. Aribal, 
SAFE: A Novel Microwave Imaging System Design for Breast Cancer Screening and 
Early Detection—Clinical Evaluation, Diagnostics. 11 (2021). 
doi:10.3390/diagnostics11030533. 
[10] MVG Industries, TN.27.1.21.MVGF.B Clinical Study Report - Wavelia FiH study, 11 
June 2021, Version B, 2021.