A Prospective, Multicenter, Nonrandomized, Open-label, Single-arm Study of the BlueDop Vascular Expert for Assessing Peripheral Arterial Disease
Conditions: Peripheral Arterial Disease
Sponsor: BlueDop Medical LTD

 
 
 
 
 
 
 
Document ref: CIP summary from 
BVE-01- v2.0 
Date: 14Feb2022 
 
 
Confidential 
                      Page 1 of 2 
 
CIP SUMMARY 
 
Clinical 
Investigation code 
BVE-01 
Title 
Clinical Evaluation of the BlueDop Vascular Expert 
for Assessing Peripheral Arterial Disease 
Objectives 
Primary objective:  
Evaluate the clinical equivalence (assessment of accuracy) of BVE as binary 
result (either presence or absence of significant peripheral arterial disease) 
compared to arterial duplex ultrasound in a group of patients referred for 
evaluation of PAD of the lower limbs when performed by a vascular specialist. 
 
Secondary objectives: 
Evaluate the clinical equivalence (assessment of accuracy) of BVE as binary 
result (either presence or absence of significant peripheral arterial disease) 
compared to ABPI in a group of patients referred for evaluation of PAD of the 
lower limbs when performed by a vascular specialist. 
Assess the safety of the BVE device. 
 
Exploratory objectives: 
Evaluation of the BVE System for clinical performance including time needed to 
perform BVE, inter-operator variability and number of BVE non-diagnostic tests. 
Device Under 
Investigation 
Bluedop Vascular Expert (BVE) 
Model: Medical BVE100 
Set 1: Tablet s/n 1001+ Charger s/n 1001 + Egg s/n 1002 
Number of 
Subjects Required 
for Inclusion in 
Clinical 
Investigation 
188 limbs required (188 subjects max., but enrolled number of subjects may be 
lower if, for certain subjects, both limbs are included in the study). 
Clinical 
Investigation 
Design 
Prospective, multi -center, nonrandomized, open label, single arm study 
Primary Endpoint 
Evaluation of clinical equivalence of BVE compared to Arterial duplex in the 
determination of presence or absence of significant PAD 
Major Secondary 
Endpoints  
• Evaluation of clinical equivalence of BVE compared to ABPI in the 
determination of presence or absence of significant PAD. 
• Evaluation of BVE safety 
Subject Follow-up 
N/A – No follow-up visits are planned in the study. 
Inclusion Criteria 
1. Subject must provide written informed consent prior to any clinical 
investigation related procedure. 
2. At least 18 years of age. 
3. Referred for duplex ultrasound of the lower limb (s) with suspected or previous 
history of peripheral arterial disease 
4. Must have an ABPI performed as part of the assessment 

 
 
 
 
 
 
 
Document ref: CIP summary from 
BVE-01- v2.0 
Date: 14Feb2022 
 
 
Confidential 
                      Page 2 of 2 
 
5. Able to obtain a brachial cuff blood pressure reading 
6. Must have a valid ankle duplex ultrasound measurement at the Posterior Tibial 
Artery (PTA) and Dorsalis Pedis Artery (DPA)  
Exclusion Criteria 
1. Subject is currently participating in another clinical investigation or has 
participated in another clinical investigation in the past 30 days prior to the 
start of the present study; 
2. Pregnant or nursing subjects and those who plan pregnancy during the clinical 
investigation follow-up period 
3. Presence of other anatomic or comorbid conditions, or other medical, social, 
or psychological conditions that, in the investigator’s opinion, could limit the 
subject’s ability to participate in the clinical investigation or to comply with 
follow-up requirements, or impact the scientific soundness. 
4. Inability of refusal to give informed consent. 
5. Lower extremity would or compromised skin of the legs that prevents access 
to the studied arteries.