Clinical Evaluation of an Intra-procedural 3D Needle Guidance Platform for Soft Tissue Tumors or Organs Requiring Percutaneous Biopsy as an Adjunct to Standard Image Guidance
Phase: NA
Conditions: Oncology, Interventional Radiology, Liver Carcinoma, Renal Carcinoma, Biopsy
Sponsor: MediView XR, Inc.

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
1
 Study Title: Clinical Evaluation of an Intra-procedural 3D Needle Guidance Platform for Soft 
Tissue Tumors or Organs Requiring Percutaneous Biopsy as an Adjunct to 
Standard Image Guidance
Principal Investigators: 
Bradley Pua, MD
Weill Cornell Medical College
525 E. 68th Street, Payson
New York, New York 
Telephone: (212)-746-2656
Email:  brp9018@med.cornell.edu
Keith Horton, MD
MedStar Washington Hospital
110 Irving Street, NW
Washington, DC
Telephone: (301)-523-0291
Email: keith.m.horton@medstar.net
Filip Banovac, MD
MedStar Georgetown University Hospital
3800 Reservoir Rd. NW
Washington, DC
Telephone: (202)-440-2000
Email: filip.banovac@medstar.net
Sub-Investigator (s):
John Smirninotopoulos, MD
(or Faculty Advisor for
MedStar Washington Hospital 
 Student projects)
110 Irving Street, NW
Washington, DC
Telephone: (202)-877-7000
Email:  john.b.smirniotopoulos@medstar.net
Study locations:
Weill Cornell Medical College
525 E. 68th Street, Payson
New York, New York 

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
2
MedStar Washington Hospital
110 Irving Street, NW
Washington, DC
MedStar Georgetown University Hospital
3800 Reservoir Rd. NW
Washington, DC
Sponsor:
MediView XR, Inc
10000 Cedar Ave STE # GCIC2-153
Cleveland OH, 44106
Telephone: 501-697-3808
Email: Michael.Evans@medivew.com

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
3
Protocol Signature Page
Protocol Title: Clinical Evaluation of an Intra-procedural 3D Needle Guidance Platform for Soft Tissue Tumors or 
Organs Requiring Percutaneous Biopsy as an Adjunct to Standard Image Guidance
Protocol Number: TP-172
Protocol Version and Date: Version 3; 02May2025
SPONSOR
I agree to the terms of the protocol. 
Sponsor Representative Name
Signature 
Date
SITE
I will conduct the study in accordance with the provisions of this protocol. I agree to conduct this study in 
compliance with United States (US) Health and Human Service regulations (45 CFR 46); applicable U.S. Food and 
Drug Administration regulations; standards of the International Conference on Harmonization Guideline for Good 
Clinical Practice (E6); Institutional Review Board/Ethics Committee determinations; all other applicable country, 
state, and local laws, and regulations. 
I have read and understand all sections of the protocol.
Principal Investigator Name
Signature 
Date

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
4
SUMMARY............................................................................................................................................................6
DEFINITIONS AND ACRONYMS (ALPHABETICAL) ...................................................................................................8
INTRODUCTION ..................................................................................................................................................10
BACKGROUND/RATIONALE.................................................................................................................................10
INVESTIGATIONAL DEVICE DESCRIPTION ............................................................................................................12
INTENDED USE.............................................................................................................................................................14
COHORT OF USERS AND POPULATION DESCRIPTION ..........................................................................................14
POPULATION ...............................................................................................................................................................14
SAMPLE SIZE AND JUSTIFICATION.....................................................................................................................................14
PARTICIPANT INCLUSION CRITERIA ...................................................................................................................................15
GENERAL INCLUSION CRITERIA: .......................................................................................................................................15
SITE AND PROVIDER INCLUSION:......................................................................................................................................16
CENTER AND PROVIDER EXCLUSION CRITERIA:....................................................................................................................16
ETHICAL CONSIDERATIONS .................................................................................................................................16
INCLUSION OF WOMEN AND MINORITIES..........................................................................................................................16
INFORMED CONSENT.....................................................................................................................................................16
IMAGING ....................................................................................................................................................................17
STUDY OBJECTIVES .............................................................................................................................................17
PRIMARY OBJECTIVE .....................................................................................................................................................17
SECONDARY OBJECTIVES................................................................................................................................................17
STUDY DESIGN....................................................................................................................................................17
STUDY ENDPOINTS .............................................................................................................................................18
PRIMARY ENDPOINTS ....................................................................................................................................................18
SECONDARY ENDPOINTS ................................................................................................................................................18
BENEFIT/RISK ASSESSMENT............................................................................................................................................19
TRAINING....................................................................................................................................................................20
STUDY PROCEDURES...........................................................................................................................................21
SCREENING AND ENROLLMENT........................................................................................................................................21
RANDOMIZATION: ........................................................................................................................................................21
ARM A (XR90 EXPERIMENTAL GROUP) PRE AND INTRAOPERATIVE STEPS: ..............................................................................21
ARM B STANDARD OF CARE SIMULATED NEEDLE PLACEMENT...............................................................................................26
COLLECTION OF DATA: ..................................................................................................................................................26

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
5
SAFETY MONITORING.........................................................................................................................................28
OVERVIEW..................................................................................................................................................................28
MONITORING PROCEDURES............................................................................................................................................28
DATA SAFETY MONITORING BOARD (DSMB)....................................................................................................................29
STOPPING REQUIREMENTS .............................................................................................................................................29
STATISTICAL ANALYSIS PLAN ..............................................................................................................................30
DATA HANDLING AND RECORD KEEPING ............................................................................................................30
GREENLIGHT GURU CLINICAL..........................................................................................................................................30
RECORD KEEPING ...............................................................................................................................................31
INVESTIGATOR RECORDS................................................................................................................................................32
INVESTIGATOR REPORTS ................................................................................................................................................32
SPONSOR RECORDS.......................................................................................................................................................32
SPONSOR REPORTS.......................................................................................................................................................32
DETERMINATION OF UNANTICIPATED ADVERSE EVENTS ....................................................................................33
DISSEMINATION OF DATA ..................................................................................................................................33
REFERENCES .......................................................................................................................................................34
APPENDICES .......................................................................................................................................................35
VERSIONS ...................................................................................................................................................................36

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
6
Summary
Protocol Title
Clinical Evaluation of an Intra-procedural 3D Needle Guidance 
Platform for Soft Tissue Tumors or Organs Requiring Percutaneous 
Biopsy as an Adjunct to Standard Image Guidance
Brief Background/Rationale
This clinical feasibility evaluation is intended to further characterize 
and quantify the potential benefits of the FDA cleared XR90 AR 
imaging and guidance platform utilization in percutaneous soft tissue 
biopsy. This study will seek to build on the findings of safety, 
procedural benefits, and overall clinical feasibility shown in previous 
bench, cadaveric, and single-site clinical evaluations.
Primary Objectives and Variables 
The primary objective of this study is to compare procedural efficiency 
(time of tumor localization, time from skin to target) of the XR90 
system when used in adjunct to standard-of-care imaging to standard-
of-care imaging alone (ultrasound/CT) for clinical percutaneous biopsy 
procedures.
Secondary Objective(s)
Secondary objectives of this study include evaluating safety, system 
utility, and system efficacy. 
Study Population
- Consentable adults
- Patients in need of standard of care (SOC) soft-tissue tumor biopsy 
where the target is visible and targetable on ultrasound; ~102 patients 
total (51 per arm) across all sites.  34 patients per study location (17 
patients in Arm A and 17 patients in Arm B)
Disease sites/Conditions
 Soft tissue tumors requiring biopsy with ultrasound as part of standard 
of care guidance
Study Workflow
-
Pre-initiation bench top education of all potential operators 
and assistants (trainees, technologists, nurses)
-
Patient consent
-
Pre-procedural cone beam CT (rotational fluoroscopy) with 
spot markers
-
Segmentation of CT data (can be anonymized)
-
Pre-procedural equipment setup 
-
Pre-procedural registration 
-
Pre-procedural tumor and trajectory localization and timing
-
Procedure using XR90 + standard of care guidance or standard 
of care guidance per randomization 

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
7
-
Procedural accuracy metrics
-
Post-procedural operator survey
Duration 
The study is expected to last for 2 years
Equipment
-
MediView to provide XR90 system and compatible 
components to enable proper functionality and data collection, 
including:
o
Fiducial markers (CT-Spot Markers)
o
Integrated ultrasound
o
HoloLens headset and storage
o
EM Navigation System
o
Triangle Template
o
Sterile ACM (i.e., Registration) Markers 
o
Disposable EM Probe Bracket 
o
Sterile CIVCO eTRAX needles 
o
Laptop with HIVE 
-
Equipment from clinical site:
o
Biopsy needle 
o
Fluoroscopy and/or CT imaging system

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
8
Definitions and Acronyms (alphabetical)
Term
Definition
ACM 
ACM Registration markers used with the 
MediView XR90 System. A sterile component 
of the XR90 system that is placed on the 
patient’s skin at CT spot marker locations in 
order to register different types of holograms. 
Three Registration Markers corresponding point 
locations in CT, EM, and Head-mounted Display 
(HMD) coordinate systems. The Registration 
Markers provide the transformations for EM-to-
HMD and CT-to-HMD coordinate system.
Adjustment 
Function
After an anatomy landmark (point marked on the CT-based holograms) and an 
ultrasound landmark (point marked on the HUD in HMD coordinates) have been 
set, the words, “Adjust Anatomy” will translate the CT-based holograms from the 
anatomy landmark position to the ultrasound landmark position.
CT
X-ray Multi-detector row Computed Tomography 
EM 
Electromagnetic (EM) tracking of sensor-equipped tools and interventional 
instruments. Also used for fiducial locations on the patient skin. 
Flashlight 
Projection 
Live streamed ultrasound 
image projected on the head 
mounted display relative to 
and extending from the 
physical ultrasound probe 
toward the phantom or patient. 
Image matches the image on 
the ultrasound scanner and 
HUD.
HLR 
Holographic Light Ray. A holographic representation of the tracked physical 
instrument including a representation of the tip. 
HMD
Head-Mounted-Display (i.e., Microsoft HoloLens)
HUD
Heads-Up Display. A virtual interactable user interface panel that also displays live 
streamed ultrasound through the HMD. The HUD is used for selection and loading 
of Holographic Anatomy, setting a virtual target and Needle Guide on the virtual 
ultrasound image, manipulating the Needle Guide handle, and interacting with 
general UI buttons through near or far interaction.

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
9
Needle 
Depth
Distance between skin insertion (percutaneous access) point and the (center of the) 
target tissue along the needle path. 
System 
Registration
System registration is defined as the estimation of a geometric transformation 
aligning objects such that the distance between corresponding points on these 
objects is minimized, bringing the objects into alignment. Objects can include a 
virtual / holographic representation of (physical) surgical instruments, virtual 
representations of (physical) anatomical structures, and virtual representations 
based on real-time imaging of anatomical structures. 
US
Ultrasound
XR-90 
(“system”)
MediView proprietary AR platform incorporating head-mounted display of 
holographic anatomy from preprocedural CT, fiducial-based intraoperative 
registration, holographic display of real-time streaming ultrasound, and EM 
tracking of ultrasound probe and sensorized needle/trocar

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
10
Introduction
Percutaneous procedures (thermal ablation, biopsy, etc.)) is a leading diagnostic and treatment mode in the growing 
field of image-guided “interventional oncology [1, 2]. One drawback is that images  are displayed table-side on 
conventional 2D flat-screen monitors, and some including CT utilize radiation [3]. 
Percutaneous biopsy is an ideal, minimally invasive way to obtain tissue to make a pathological diagnosis and is 
standard of care for many cancers. Biopsies are often sampled from tumors in difficult-to-access or otherwise 
sensitive locations, and current image guidance is often not ideal due to the same issues with two-dimensionality 
which often leads to increased procedure and examination time often resulting in increased radiation exposure
Instead of using such flat screen displays, this pilot evaluation will provide 3D holographic visualization of target 
tumors and augment the navigation of tracked instruments directly to the biopsy target. 
MediView XR90 Holographic Surgical Navigation System 
Background/Rationale
Augmented Reality (AR) places digital content into the real world through a display device such as the Microsoft 
HoloLens. The user can visualize both the real world and digital content at the same time. In healthcare, the use of 
AR to deploy 2D and 3D objects has been shown to improve ergonomics, patient monitoring, and workflow [4].  AR 

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
11
may provide enhanced tumor visualization and location, leading to increased, and more efficacious, percutaneous 
procedures AR may help to facilitate ideal probe/needle planning and trajectory by allowing providers to visualize 
their intended target in a 3D space [5].
Percutaneous biopsy is an ideal, minimally invasive way to obtain tissue to make a pathological diagnosis, stage or 
monitor disease progression or response to treatment. Biopsies are often sampled from tumors in difficult to access 
or otherwise sensitive locations. Sub-centimeter accuracy is required for these minimally invasive percutaneous 
procedures to have clinical benefits for patients [6-9]. Near perfect accuracy is required to prevent injury and 
enhance the success of obtaining an adequate tissue specimen. A primary factor limiting percutaneous therapies is 
the quality and nature of image guidance currently available to operators, making the required accuracy challenging 
to achieve [10].
Surgical navigation systems aim to improve image guidance and have been shown to improve percutaneous needle-
based procedures by improving targeting accuracy and decreasing the number of intraprocedural CT scans required 
to achieve correct placement [11, 12]. The standard of care image guidance utilized for these procedures, primarily 
US and CT, are limited by two-dimensional projections of inherently complex 3D anatomy, and, for the latter, the 
need for ionizing radiation. Multimodal image fusion platforms can help improve depth perception and spatial 
anatomic understanding [13, 14]. Head-mounted-display-based multimodal image fusion AR platforms such as XR90 
provide improved depth perception and spatial understanding, while also allowing true three-dimensional and even 
interactive projections [15, 16]. The use of AR for surgical navigation may potentially improve operator confidence 
and facilitate percutaneous procedures on more challenging targets that would not be appreciable with only standard-
of-care guidance. Furthermore, the use of AR for percutaneous procedures can reduce the risk of injury by enhancing 
the accuracy of needle placement and providing visualization to avoid critical structures [4, 5, 16, 17].
Studies have demonstrated the XR90 system’s efficacy and accuracy in both benchtop and cadaveric environments 
(within 5mm). Early in-human clinical usability evaluations of the XR90 platform were performed as an adjunct to 
standard-of-care imaging in 12 patients for percutaneous thermal ablation of abdominal soft tissue tumors, 
predominantly of the liver and kidney. The results of the study demonstrated early clinical feasibility and potential 
benefits of the system. [16]
This clinical evaluation is needed to further characterize and quantify the potential benefits of percutaneous biopsy, 
assisted with the XR90 3D surgical imaging system. This continued innovative implementation of the platform as a 
medical device to assist in percutaneous targeted biopsy of soft tissue tumors will allow for further assessment of 
device functionality, operator acceptability, and additional data collection to help quantify the potential benefits of 
this platform. 
Potential benefits to the patient, to be formally proven in future studies: decreased procedure time, decreased of 
complications (e.g., critical structure avoidance), and ultimately, improved patient outcomes.
To date, few studies have evaluated the performance  of the XR90 guidance system in a clinical setting. Comparing 
percutaneous needle placement for biopsies of a soft tissue target with the assistance of XR90 compared to under 
only standard-of-care guidance will allow for the evaluation of procedure success rate, , overall procedure time, and 
complications.  This multicenter prospective randomized control trial is designed to compare the efficacy and utility 
of the XR90 guidance platform used adjunct to standard of care guidance to standard of care guidance (2D) only for 
percutaneous needle-based procedures.

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
12
Investigational Device Description
The MediView™ XR90 system is an augmented reality-based medical device to be used adjunctively to clinical 
ultrasound (US) systems, with the ability to holographically display and fuse standard-of-care US with digital 
anatomical models based on computed tomography (CT) imaging. The XR90 system provides navigational guidance 
and remote collaboration features. The system is comprised of a commercial, off-the-shelf augmented reality head-
mounted display, wirelessly connected to a streamer that interfaces with commercially available ultrasound system 
and an electromagnetic (EM) field generator. The US signal is transmitted from the streamer to the head-mounted 
display, where a holographic display of the US image is stereoscopically projected into the user’s field of view. A 
proprietary algorithm for EM and optical tracking registers the CT holograms to the operative site and is fused with 
the live US projection. The XR90 system provides unconstrained orientation (position, scale, and rotation) of the US 
image to the proceduralist in a convenient and contextual location by viewing the US image, physical US probe, 
interventional instrument, and hands all within the operator’s field of view via two modes of viewing. First, the 
virtual heads-up display (HUD) streams the ultrasonic image from a local compatible US system, provides access to 
system information and status, and enables users to set a Holographic Needle Guide. Second, the Flashlight mode 
enables a proceduralist to holographically project the same streamed ultrasonic image coaxially from the ultrasound 
transducer in real-time using an EM-tracked probe bracket, which provides additional context to the proceduralist. 
Users may choose a point of interest on the HUD and instantiate a virtual needle trajectory (“Holographic Needle 
Guide”) both on the HUD and in relation to the Flashlight. XR90 is intended to be used adjunctively to diagnostic 
imaging per standard of care and provides navigational guidance to the user. Always refer to standard of care and 
prioritize clinical experience or judgment when using the XR90 system. XR90 is not intended to be the sole 
guidance for any procedure.

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
13
Figure 1: Depiction of three main registered projections visible to the operator when using the AR platform. 1 
3D anatomical models, such as bone (white, liver (green) and kidney (yellow). 2 Ultrasound Flashlight: projected 
coaxially with echogenic target. 3 Holographic Light Ray in dark green. An additional needle guide feature is 
displayed in orange.
XR90 is a 510K cleared device (K223125). The system has been cleared for use as an adjunct to the standard of care 
in needle-based, ultrasound-guided procedures.  Additional features have been added to the system to assess their 
usability in a clinical setting that the FDA has not evaluated, including the ability to utilize voice commands to 
record metrics such as needle depth and procedure time and the ability of the provider to upload images directly onto 
the system.  
A list of the voice commands is listed below:
•
Log Procedure Start- creates a timestamp of the procedure start time.
•
Log localization start- creates a timestamp of the time localization is started.
•
Log localization end- creates a timestamp of the localization ending.
•
Log targeting start- creates a timestamp at the start of targeting.
•
Log targeting end- creates a timestamp of the end of targeting.  Also records the EM vector position of the 
needle tip for needle depth.
•
Log Needle Redirect- creates a tally log of the number of needle redirects required during the procedure.
•
Log Attempt- creates a tally of log of the number of attempts needed during the procedure.
Voice commands were verified during the design control process of the XR90 system via TR-105 and demonstrated 
that when a voice command was used, the system performed as intended.  
 

Clinical Protocol Form
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Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
14
In addition to voice commands for research software has been included to allow for the investigator to directly 
upload segmentation files without interacting with the noncustomer-facing portal which is required under the current 
workflow. This will decrease the time spent waiting on staff to upload segmented Cone beam CT files during the 
procedure. 
Intended Use
The XR90 (XR90-SYS) is a medical display workstation intended for 3D image visualization and image interaction 
in conjunction with traditional imaging and monitors. The virtual images are generated from tracked Ultrasound, 
tracked interventional device, and 3D volumetric data acquired from CT sources and stereoscopically projected such 
that the proximity of the virtual interventional device is displayed relative to live ultrasound and 3D models from 
previously acquired CT. The device is intended to provide visual information and reference to be used by the health 
care professionals for analysis of surgical options during pre-operative planning, and the heads-up, intra-operative 
display of the images during ultrasound-guided needle-based procedures.  Virtual images on the heads-up display 
should always be used in conjunction with traditional monitors. 
The XR90 (XR90-SYS) system is intended to be used as an adjunct to the interpretation of images performed using 
diagnostic imaging systems and is not intended for primary diagnosis.  
The XR90 (XR90-SYS) system is intended to be used as a reference display for consultation and guidance to assist 
the clinician who is responsible for making all final patient management decisions.  
During system use, the position and orientation tracking of the interventional instruments should always be available 
to the clinician on traditional imaging and monitors. 
  
Cohort of Users and Population Description
This is intended to be a multi-site prospective randomized control trial. This device evaluation will include 
participants undergoing a diagnostic US-guided percutaneous  soft tissue biopsy as a part of their standard of care. 
Population
 All qualified adults referred to IR for needle-based, percutaneous soft tissue tumors  requiring biopsy with 
ultrasound as part of standard of care.
Sample Size and Justification
The enrollment goal of this study 34 participants per study site (17 patients in Arm A and 17 patients in Arm B) for 
a total of 102 participants.

Clinical Protocol Form
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Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
15
This study is designed to compare the procedural efficiency of the XR90 system with standard-of-care (SOC) 
imaging in percutaneous biopsy procedures. We focused on detecting clinically meaningful differences for the 
primary endpoints of: time of tumor localization, and skin to target time. 
1.
Primary Endpoints: Time of Tumor Localization and Time from Skin to Target
The time from initiation of localization to planned trajectory and skin to target will be measured as described in 
the Endpoints and Study Design section of this protocol. To ensure the study is adequately powered for a continuous 
outcome, a two-sample t-test was used to determine the required sample size. Given the presence of two primary 
endpoints, a Bonferroni correction was applied to control for the overall Type I error rate. The total two-sided alpha 
of 0.05 was split evenly between the two endpoints, resulting in a significance level of 0.025 for each primary 
comparison.
For time of tumor localization, we assumed a SOC mean of 15 minutes with a standard deviation (SD) of 3 minutes, 
targeting a 2-minute difference. These estimates were based on current literature and preliminary data comparing 
Arm A (XR90) to Arm B (SOC )in porcine models [18, 19]. Under these assumptions and using a two-sided alpha 
of 0.025, a total of 89 participants (approximately 45 per group) are required to achieve 80% power to detect this 
difference.
Similarly, for time from needle placement into the skin to entry into the target, we assumed an SD of 4 minutes and 
a clinically meaningful difference of 3 minutes. Using the Bonferroni-adjusted alpha of 0.025 and targeting 80% 
power, the required total sample size is 71 participants (approximately 36 per group).
The planned enrollment of approximately 102 participants exceeds the minimum required sample sizes for both 
primary endpoints after adjustment for multiple comparisons, ensuring the study remains adequately powered to 
detect the targeted effects while controlling the overall Type I error rate at 5%.
This protocol specifies an enrollment goal of 102 subjects. This study is adequately powered to evaluate the utility 
of the investigational device and detect a meaningful difference between XR90 and SOC.  
Participant Inclusion Criteria
Participants will be considered suitable if they fulfill all the Inclusion Criteria. General inclusion criteria 
will be assessed during the initial patient evaluation by conducting a history and physical examination. 
General Inclusion Criteria:
1.
At least 18 years of age.

Clinical Protocol Form
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Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
16
2.
Willing and able to give informed consent prior to enrollment. 
3.
Subjects in need of a diagnostic soft-tissue tumor biopsy which is the primary target 
for needle placement as a part of their standard of care. .
4.
Has met all criteria to undergo percutaneous biopsy with ultrasound.
5.
Subjects with soft-tissue lesions ≥1 cm or ≤8 cm in depth
6.
BMI of ≤40
1.
General Exclusion Criteria 
1.
Children under the age of 18. 
Currently pregnant at the time of the procedure 
2.
Not willing or able to give informed consent.
3.
Subjects with pacemakers or AICDs. 
Site and Provider Inclusion:
1.
Three sites who routinely perform percutaneous needle-based procedures as a part of their practice.
2.
Attending providers who specialize in interventional radiology and who perform >10 needle-based 
procedures every 12 months will be recruited for the study.
3.
 Physician Assistants who specialize in interventional radiology and who perform >10 needle-based 
procedures every 12 months will be recruited for the study
4.
 PGY5-7 interventional radiology residents may also participate in the procedure when under the 
supervision of a qualified attending.
Center and Provider Exclusion Criteria:
1.
Medical Attendings who do not specialize in interventional radiology.
2.
Medical Attendings who have not performed > 10 needle-based procedures in the past 12 months.
3.
PGY4 or less residents
4.
Physician Assistants who do not specialize in interventional radiology or have not performed > 10 needle-
based procedures in the past 12 months
Ethical Considerations
This study will be conducted in accordance with the submitted protocol, GCP (good clinical practice) guidelines, 
and all applicable government regulations and policies and procedures.  This protocol and any amendments will be 
submitted and approved by the Institutional Review Board (IRB) to conduct the study.  
Inclusion of Women and Minorities 
Adult men, adult women, and members of all races, ethnic groups, and genders are eligible for this trial.
Informed Consent
The formal consent of each subject, using the IRB-approved consent form, will be obtained before that subject is 
submitted to any study procedure.  All subjects for this study will be provided a consent describing this study and 
providing sufficient information in language suitable for subjects to make an informed decision about their 

Clinical Protocol Form
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Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
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participation in this study.  The person obtaining consent will thoroughly explain each element of the document and 
outline the risks and benefits, alternate treatment(s), and requirements of the study.  The consent process will take 
place in a quiet and private room, and subjects may take as much time as needed to make a decision about their 
participation.  Participation privacy will be maintained and questions regarding participation will be answered.  No 
coercion or undue influence will be used in the consent process.  This consent form must be signed by the subject, 
and the person obtaining the consent.  A copy of the signed consent will be given to the participant, and the 
informed consent process will be documented in the research record.  
Imaging 
Various videos and photographs will be taken during the procedure for the purpose of documentation and record 
keeping.  Media will be collected by dedicated MediView support personnel or dedicated research support staff 
unless collected from the first-person viewpoint of the operator wearing the HoloLens2.  Media collection will not 
be allowed to interfere with the efficiency of the procedure.  
Study Objectives
Primary Objective
The primary objective of this study is to compare procedural efficiency (time of tumor localization, time from skin 
to target) of the XR90 system when used in adjunct to standard-of-care imaging to standard-of-care imaging alone 
(ultrasound/CT) for clinical percutaneous biopsy procedures.
Secondary Objectives
Secondary objectives of this study include evaluating safety, system utility, and system efficacy.  
Study Design 
1.
Design
 Patients scheduled to undergo a biopsy as part of their standard of care treatment by a participating provider will be 
assessed for eligibility and if interested, consented for the study. The trial will be structured as a standard two-arm, 
parallel design, individually randomized prospective trial. Patients will be randomly assigned to either Arm A or 
Arm B for the study.  . This trial is open label for the provider but closed for the subject. 
Arm A (XR90 Experimental Group): Participants randomly assigned to this arm will undergo 
percutaneous biopsy procedures using the assistance of XR90 guidance system in adjunct to 
standard of care guidance.  XR90 is not intended to be used as sole standard of care for needle 
guidance. The XR90 system and GE ultrasound, and all disposables needed will be provided by 
the study sponsor.   

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
18
Arm B (Standard of Care Group): Participants randomly assigned to this arm will undergo 
percutaneous biopsy with standard of care CT and ultrasound needle guidance only.  
2.
Randomization
After patients have been screened and enrolled in the study, research staff will create the subject in the EDC and 
they will be automatically randomized to either arm A or B in the EDC. Patients will have an equal chance of being 
assigned to either group.   Randomization will be blinded to subjects but open to providers. 
Study Endpoints
Primary Endpoints
1.
Time of Tumor Localization: 
a.
Arm B (Standard of Care Arm): The time from initiation of localization of standard imaging (defined 
by when the ultrasound probe is put into operator’s hand) until operator has planned a trajectory and 
point of entry (by placing a finger or trocar on the skin entry site and verbalizing completion of 
localization) will be measured and recorded.
b.
Arm A (XR90 Guided): The time it takes from initiation of localization using the platform (defined by 
when the sensorized instruments are first put in the operator’s hand) until the operator has planned a 
trajectory and point of entry (by placing finger or trocar on the skin entry site and verbalizing 
completion of localization) will be measured and recorded.
2.
Time From Skin to Target
a.
Arm B (Standard of Care Arm): The elapsed time from when the proceduralist inserts their trocar or 
biopsy needle through the skin (excluding skin knicks) and when the provider verbalizes they have 
reached their intended target in order to collect a biopsy under ultrasound guidance.
b.
Arm A (XR90 Guided): The elapsed time from when the proceduralist inserts their trocar or biopsy 
needle through the skin (excluding skin knicks) and when the provider verbalizes they have reached 
their intended target in order to collect a biopsy using XR90 as an adjunct to ultrasound guidance.
Secondary Endpoints
1.
System Utility 
a.
Procedure technical success- the completion of biopsy procedure. Procedures will be determined to 
be complete once the provider has verified (via ultrasound or CT) the trocar has reached the intended 
target, as if the proceduralist were to ablate or biopsy. 
b.
Assessment of biopsy difficulty and sample adequacy
i.
Biopsy difficulty will be evaluated objectively according to the depth of lesion  and 
subjectively on a scale of 1-10 (10 being most difficult) by the operating provider after the 
procedure.

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
19
ii.
Sample adequacy will be evaluated by measuring diagnostic yield as a binary outcome 
(Yes/No): Whether the biopsy led to a definitive pathological diagnosis
c.
Needle attempts: An attempt shall be defined as the entrance of the needle into the skin with the 
planned advancement of the needle toward the targeted lesion. An attempt will be counted at the 
beginning of targeting and each time an operator removes their needle from the skin and restarts 
localization.  We anticipate no significant difference between the number of needle attempts performed 
with 2D standard of care modalities as compared to those performed using the XR90 guidance system 
in adjunct to standard of care.
d.
First attempt success: Was the proceduralist able to successfully obtain a specimen without having to 
remove a needle from the skin and re-inserted with a different trajectory. Yes or No. We anticipate no 
significant difference of First Attempt Success rate for procedures performed with 2D standard of care 
modalities as compared to those performed using the XR90 guidance system in adjunct to standard of 
care.
e.
Post procedure user usability survey 
2.
System Efficacy: We anticipate the system will perform according to the intended use statement.
a.
Error messages displayed by the device will be recorded.
b.
Records will be kept of any adverse events related to the medical device.
c.
Operators will participate in a survey subjectively evaluating the efficacy of the system.
3.
Safety:
a.
Procedural complications: Complications such as prolonged bleeding requiring escalation of the case 
(transfusion, admission, etc.), bile duct injury, vascular injury, urinary tract injury burns that occur 
during the procedure will be recorded. We anticipate that there will not be a significant difference in 
the rate of complications that occurs in the procedure performed with XR90 guidance when compared 
to procedures performed under only 2D standard-of-care. 
b.
Critical structure avoidance: The inadvertent puncture of a critical structure which would routinely 
be avoided during a biopsy procedure will be noted.  Critical structures will be defined as any 
anatomical structures with the potential to cause escalation of the case or long-term complications such 
as prolonged hospital stay.
 
Benefit/Risk Assessment
This study will be used to support the following benefits/claims of the XR90 system:
•
XR90 can assist a proceduralist in gross localization of tumors imaged under ultrasound using the 
combination of ultrasound Flashlight and CT-based Holographic Anatomy.

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
20
•
The registered images in XR90 enables intra-operative display of the virtual instrument location in relation 
to the virtual anatomy and ultrasound to assist in spatial understanding, visualization, and trajectory 
planning.
•
XR90 provides in-plane or out-of-plane needle guidance to navigate a virtual representation of an 
interventional instrument to a desired virtual target location.
•
XR90 will not increase the amount of complications that occur during percutaneous needle base 
procedures. Complications after percutaneous procedures vary widely and can occur in up to 10% of 
patients. Complication that occur after percutaneous procedures often include bleeding, infection, bile duct 
injury, burns hepatic vasculature damage, pulmonary complications, and liver failure. [24-27] 
Complications that occur during the simulated procedure will be recorded. We anticipate that there will not 
be a significant difference in the rate of complications that occurs in the procedure performed with XR90 
guidance when compared to procedures performed under only 2D standard-of-care. 
Risks have been identified through the MediView Risk Management process in accordance with ISO 14971:2019 
“Medical devices – Application of risk management to medical devices,” and residual Medium or High-level risks 
will be evaluated throughout the course of this study to support a conclusion that the benefits of the XR90 system 
outweigh the risks during a procedure.
Harm is defined as physical injury or damage to the health of people, damage to property or the environment. The 
Risk Management File identified thirty-seven (37) types of harms that have a post-risk mitigation risk level of 
Medium or High, which are known as potential adverse events (AEs) associated with the XR90 system. Of these 
thirty-seven (37) types of harms identified, 35 of them cause damage to the patient’s anatomy due to the needle 
taking the wrong trajectory. The remaining two harms are a burn due to fire and risk of explosion. The details of 
each harm, including sources and controls, are in the Risk Management File and PDPROJ-4.0 BRA, Benefit/Risk 
Analysis, XR90.
Training
1.
Provider Training:
1.
Providers will undergo benchtop training with the XR90 system prior to performing clinical cases. Training 
includes: 1) positioning and adjustment of the headset, 2) use of the sensor-equipped ACMs, 3) placement 
of sensor-equipped fiducial markers, 4) localization of a tracked device relative to anatomical holograms as 
an adjunct to standard flat panel monitors for ultrasound and fluoroscopic imaging per standard of care, 5) 
use of HoloLens 2 voice commands and holographic dashboard, 6) use of projected sonography, 7) 
measurement of relevant intraprocedural metrics 
2.
A bench set-up will enable training for use of the HoloLens 2 HMD.  This is based on Computerized 
Imaging Reference Systems (CIRS) models including, but not limited to, Model 071 and Model 057A.  The 
bench set-up will be used to align a needle and sensor-equipped co-axial stylet with tumor targets within 
the phantoms. 
3.
Training Target Criterion: The proceduralist must accurately place the needle in 10 targets ranging in depth 
from 3 to 10 centimeters at site initiation visit or early on-site training.

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
21
2.
Lab Technologist Training:
1.
The support staff will be trained on positioning the mobile console and the EM generator in the 
interventional suite prior to clinical use.
2.
The technologist will also be trained in appropriate and sterile handling of all intraprocedural equipment.
Study Procedures
Screening and Enrollment
1.
Subjects will be screened as they are scheduled for biopsy procedures. 
2.
Subjects will be invited to participate in the study and must sign an informed consent before initiating any 
study procedures.
Randomization:
After the subjects have signed the  consent, subjects will be randomized to either Arm A (XR90 experimental group) 
or Arm B (standard of care).  Randomization will occur in the EDC.  
Arm A (XR90 Experimental Group) Pre and Intraoperative Steps:
1.
System Setup (10-15 minutes)
1.
Position the ultrasound cart equipped with MediView XR90 components at tableside to enable viewing of the 
commercially available ultrasound system ultrasound monitor and connection of EM tracking cables while 
maintaining a minimum distance of 1 meter between the EM Field Generator and the ultrasound cart. Confirm 
there is at least a 1-meter separation between the ultrasound cart and procedure table.
2.
Install the EM Field Generator on the underside of the patient table using brackets that attach to the tabletop edges 
(see figure below). Connect the EM Field Generator cable to the SCU.  
2.
Preoperative Steps
All procedures for this study will take place in an IR CT Angio Suite equipped with a C-Arm, carbon fiber table and 
an ultrasound system.

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
22
Pre-Procedure Cone Beam CT or CT Acquisition
1.
Cone Beam CT or CT scans will be acquired the day of the procedure per data acquisition protocol for the 
specified indication.
2.
Position the subject on the Angio table same way they will be positioned for the procedure (Ex: supine). 
3.
Place the Triangle Template with respect to the expected needle entry point, such that three points are not 
interfering with the proceduralist’s working space. As much as possible, center the triangle template around the 
area of interest.
Depiction of triangle template placement with liver as primary area of interest.
4.
Mark three holes with ink in the Triangle Template. 

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
23
5.
Cover the marks with radiopaque CT markers (Beekly spot marker). 
Depiction of Spot Marker placement for pre-procedure CT with Live as primary area of interest.
Reconstruction
Apply noise reduction algorithm during reconstruction with a medium level of noise reduction, (scanner specific, ex: 
Canon – AIDR, GE – ASiR, Philips – iDOSE, Siemens – SAFIRE). 
1.
Perform reconstruction to thin slices as follows: 
•
 1.0 mm thickness
•
0.8 mm increments 
Note: Raw data should be stored per institutional protocol to allow for later reconstructions, if necessary.
2.
Expiratory breath hold as per provider preference. 
3.
In the event that the 3 CT markers are unable to be seen on the scan (due to limitations of the field of view of 
the CBCT scanner), the participant will be transitioned to Arm B and the procedure completed as per SOC.
4.
 Remove radiopaque CT markers and cover ink marks with adhesive covers (point guards).
5.
Inform the subject, that the point guards must be worn between the CT scan and the procedure.  Patients can 
shower normally. Bathing, hot tubs, swimming, and vigorous scrubbing over the covers should be avoided. 
Note: Pre-operative CT scans are routine and clinically indicated and do not represent additional radiologic 
imaging or patient radiation dose

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
24
4.
Operating provider will provide the research personnel or MediView staff with a description of the target 
(location and dimensions), a list of desired anatomy for segmentation, and any specific phases that should be 
included for segmentation. No identifiable patient information should be included on this form.
Post-processing CT Data Set
1.
The tumor, target organ (liver, abdomen/peritoneum, kidney, bone, or other soft tissue area), surrounding 
organs (e.g. gallbladder/bile ducts, spleen, pancreas, bowel), other surrounding soft tissue, skin, arteries, veins, 
and nearby bone surfaces (as well as fiducial marker locations) are segmented from pre-operative CT using an 
AI algorithm designed by the investigator team at Weill Cornell Medicine.
2.
Region growing, contouring, and semi-automated organ segmentation will be performed by experienced 
research personnel with supervision of the operator. 
3.
Segmentation results will then be uploaded into XR90 for intra-procedural use.
4.
These segmentation results will be represented in the 3D surface models and imported to HoloLens.  
5.
Anatomical 3D surface models will include:
6.
Skin, individual fiducial markers, bone, organ of interest (kidney for a kidney biopsy, or liver for liver biopsy, 
etc.) tumor(s) for target, surrounding vasculature, and critical structures near the organ of interest as identified 
by the provider (e.g., portal vein, renal collecting duct, etc.)
7.
Optional anatomical features include: lungs, specified retroperitoneal organs (liver, kidney, gallbladder, etc.), 
specific veins, arteries, may be segmented at an operator's request.
8.
The time it takes for the pre-procedural process for each case, including segmentation time, and any 
quantifiable resources/cost, can be measured and recorded as needed for future evaluation.
3.
Intraoperative Steps 
Tumor Localization with XR90 Guidance
1.
Subjects will undergo standard surgical preparation and induction of anesthesia/sedation.  
2.
Position the subject on the table with the region of interest/abdomen approximately centered in the EM 
measurement volume above the generator.
3.
While subject is undergoing anesthesia induction operator dons the HMD and initiates the XR90 application. 
4.
Attach the EM Probe Bracket to the C1-5 ultrasound probe and connect its EM sensor cable to the SCU. 
5.
Place three Registration Markers (Orange, Green, and Blue) at the skin ink mark locations. For each Registration 
Marker, the alignment cross is centered on the skin mark.  Each Registration Marker cable is connected to the 
SIU. Follow the process defined in LBL-0033. Use additional adhesive (such as Steri Strips or Tegaderm) if 
needed. 
6.
Use a near or far interaction to open the Patient Selection Menu on the HUD if not open. Select the subject’s 
name to load the CT-based Holographic Anatomy.
7.
Verify system readiness with EM tracking status indicator on the HUD according to LBL-0033. All tracked 
devices should display a green checkmark status indicator in the upper right corner of the HUD. If tracked devices 
are in the measurement volume and status indicators are red, check for metal in proximity with the EM generator 
(be sure the C-arm is parked in the home position).

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
25
8.
Adjust the HUD to the preferred position and scale using near or far interactions.
9.
Perform system registration by selecting the “Start Registration” button on the HUD or saying the voice 
command “Start Registration.” Gaze at each of the three Registration Markers one at a time until the 
MediView logo appears over each. 
10. Activate the ultrasound Flashlight view (by pushing the button on the HUD or by saying the voice command, 
“Flashlight On” aloud). At this point, start the localization timer.
11. If desired a holographic needle guide (pictured below) may be placed and used to trajectory planning in order 
to assist with the avoidance of critical structures and minimize new attempts and redirects.
a.
If desired, instantiate a Needle Guide, tap a target within the ultrasound cone on the HUD using
a near or far interaction. The Needle Guide will instantiate both on the HUD and with respect to 
the Flashlight projection and will be synchronized, providing pre-operative planning and intra-
operative visualization to the user. Only one Needle Guide may be instantiated at a time. XR90 
can switch between in-plane and out-of-plane approaches using the “Lock In- Plane” or “Lock 
Out-of-Plane” voice commands. 
b.
Once the Needle Guide instantiates, you have the option to hide it. This button will appear when 
you focus on the Needle Guide handle via near or far interaction. Focusing with eye gaze is not 
supported with the Needle Guide. 
c.
A user may grab the green handle of the needle, otherwise known as the Needle Guide handle, to 
change the orientation of the Needle Guide. The Needle Guide may only be adjusted on the HUD. 
Any changes to the Needle Guide on the HUD will be simultaneously changed on the Needle 
Guide with respect to the Flashlight. 
12. The tracked interventional instrument (e.g., a sensor-equipped trocar) will be positioned prior to 
percutaneous access in accordance with the treatment plan using standard ultrasound, fluoroscopy, and 
cone-beam CT guidance as needed. The XR90 platform alone will not be used for the final position of the 

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
26
trocar prior to percutaneous access. Standard of care US will be used for all diagnostic purposes during the 
procedure.  Images and videos will be recorded from the HoloLens.
13. Video and images may be captured from the HoloLens.  Ultrasound and fluoroscopy screen captures will 
be acquired. 
14. After positioning the interventional instrument (e.g., a sensor-equipped trocar) for percutaneous access, the 
trocar will be advanced using XR90 in adjunct to standard image guidance.  Patients will receive standard 
of care with primary guidance for placement of probe/biopsy needle under ultrasound, CBCT, and 
(including the use of additional FDA cleared needle guidance or image fusion systems that may be 
available and normally used as standard of care). 
15. The trocar and/ or biopsy needle placed with standard image guidance is then advanced according to 
standard of care.  
Arm B Standard of Care Simulated Needle Placement
1.
For patients randomized into the standard arm (B) the same protocol will be followed as described above 
except for the absence of the XR90 system including the EM generator, HMD, and registration markers. 
2.
Percutaneous biopsies will be performed with 2D CT and ultrasound guidance. 
a.
Needle gauge selection will be provider preference.
b.
Must be commercially available ultrasound system.
3.
The operator uses standard of care 2D imaging to guide the needle to the target. 
4.
Record the localization time using standard of care imaging.
Collection of Data:
Study coordinators will be responsible for the collection of data and entry in Greenlight Guru Clinical for both 
Group A and Group B.  MediView support staff provide training to study personnel for the collection of data and 
study management. Providers will be responsible for performing the procedure, noting attempts, and any critical 
structures if unintentionally encountered.   The study coordinator will record all metrics in a designated data 
collection sheet via electronic study management system.  
1.
Time of Tumor Localization: 
a.
Arm B (Standard of Care Arm): The time from initiation of localization of standard imaging 
(defined by when the ultrasound probe is put into operator’s hand) until operator has planned a 
trajectory and point of entry (by placing a finger or trocar on the skin entry site and verbalizing 
completion of localization) will be measured and recorded.
b.
Arm A (XR90 Guided): The time it takes from initiation of localization using the platform 
(defined by when the sensorized instruments are first put in the operator’s hand) until the operator 
has planned a trajectory and point of entry (by placing finger or trocar on the skin entry site and 
verbalizing completion of localization) will be measured and recorded.
2.
Time From Skin to Target

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
27
a.
Arm B (Standard of Care Arm): The elapsed time from when the proceduralist inserts their trocar 
or biopsy needle through the skin (excluding skin knicks) and when the provider verbalizes they 
have reached their intended target in order to collect a biopsy under ultrasound guidance.
b.
Arm A (XR90 Guided): The elapsed time from when the proceduralist inserts their trocar or 
biopsy needle through the skin (excluding skin knicks) and when the provider verbalizes they have 
reached their intended target in order to collect a biopsy using XR90 as an adjunct to ultrasound 
guidance
3.
Assessment of biopsy difficulty and sample adequacy
a.
Biopsy difficulty will be evaluated objectively according to the depth of lesion  and subjectively 
on a scale of 1-10 (10 being most difficult) by the operating provider after the procedure.
b.
Sample adequacy will be evaluated by measuring diagnostic yield as a binary outcome (Yes/No): 
Whether the biopsy led to a definitive pathological diagnosis
4.
Needle attempts: An attempt shall be defined as the entrance of the needle into the skin with the planned 
advancement of the needle toward the targeted lesion. An attempt will be counted at the beginning of targeting 
and each time an operator removes their needle from the skin and restarts localization.  
5.
First attempt success: Was the proceduralist able to successfully obtain a specimen without having to remove a 
needle from the skin and re-inserted with a different trajectory. Yes or No. .
6.
Procedure Technical Success: Procedures will be determined to be complete once the provider has verified 
(via ultrasound or CT) that an adequate biopsy specimen has been obtained per standard of care. Categorical 
Y/N value
7.
Needle placement depth Distance between skin insertion (percutaneous access) point and the (center of the) 
target tissue along the needle path. Before removing the etrax needle from the subject, the provider will place 
their hand at the tip of the skin and hold their hand in place as they remove the needle.  Calibrated calipers will 
be used to measure the distance from the providers hand to the depth of the needle.
8.
Complications- participants will be monitored for at least 2 hours after the procedure.  Any complications 
noted to occur before discharge or during the procedure will be recorded.  Possible complications include but 
are not limited to the following:
a.
Prolonged bleeding requiring escalation (transfusion, admission, or prolonged monitoring)
b.
Bile duct injury
c.
Vascular injury
d.
Urinary tract injury
e.
Prolonged hemodynamic instability requiring intervention (unplanned fluid bolus, medication administration, 
unplanned admission, etc.)
9.
Total in-room time of participant: the elapsed time between when the participant enters the rooms and when 
the participant exits the room after completion of the procedure.
10. Critical Structures encountered: Critical structures unintentionally encountered by a provider will be noted by 
the operator and recorded by a research coordinator or MediView staff present at the procedure. A critical 
structure to be avoided include:
a.
Central Biliary tree including Gallbladder
b.
Portal Vein
c.
Inferior Vena Cava
d.
Aorta
e.
Spleen
f.
Bowel

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
28
g.
Renal collecting duct (unless targeted for biopsy)
h.
Pleura/lungs
11. Operator Survey
a.
Likert based survey questionnaire given to the primary operator prior to and following the procedure, 
evaluating:
i.
Ergonomics/comfort
ii.
Distraction introduced by the HMD
iii.
Operator confidence (esp. in terms of anatomic complexity)
iv.
Potential benefits in terms of case planning, speed, , complexity, safety
v.
Overall usability
12. Error Messages: Error messages displayed on the HUD of XR90 will be recorded.  Error messages will be 
recorded in the procedural logs of the XR90 system or may be read out loud by the proceduralist wearing the 
device.  The research coordinator will be provided an unaltered copy of the procedural log following the 
completion of each case. 
Safety Monitoring
Overview
The safety of participants enrolled in this clinical investigation will be continuously monitored throughout the study. 
This includes the systematic collection, documentation, and evaluation of all adverse events (AEs), serious adverse 
events (SAEs), device deficiencies, and any unanticipated adverse device effects (UADEs). The primary objective is 
to identify any safety issues related to the investigational device and take appropriate action to mitigate risks
Monitoring Procedures
1)
All study sites will be monitored regularly by a Clinical Research Associate (CRA) to ensure protocol 
compliance and accurate data collection. Safety data will be collected at each study visit through:
a)
Procedural Data Collection, including any procedural complications both related and unrelated to the 
device
b)
Device error messages
c)
Device performance assessments
All safety events will be recorded in the case report form (CRF), including the severity, relationship to the device, 
action taken, and outcome.
Reporting Requirements
Investigators must report all SAEs to the sponsor within 24 hours of awareness.
UADEs must be reported to the appropriate regulatory authority (e.g., FDA) and Institutional Review Board within 
10 working days of sponsor notification.

Clinical Protocol Form
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Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
29
Data Safety Monitoring Board (DSMB)
An independent DSMB will review cumulative safety data at a quarterly interval. The DSMB is authorized to 
recommend protocol modifications, temporary suspension, or early termination of the study in the event of 
significant safety concerns.
Stopping Requirements
Study-Wide Stopping Criteria
The sponsor, DSMB, or regulatory authorities may suspend or terminate the study under any of the following 
conditions:
1.
Unacceptable Risk to Participants:
a.
Two or more serious adverse events (SAEs) are determined to be directly related to device.
b.
A pattern of moderate or severe AEs suggests a safety risk associated with the device’s 
functionality or its use in the target population.
2.
High Rate of Device Malfunction:
a.
If ≥12% of enrolled participants experience device malfunctions that could reasonably lead to 
diagnostic or therapeutic error, the study will be paused pending investigation and corrective 
action.
3.
Security or Privacy Breach:
a.
Discovery of a cybersecurity vulnerability or data breach involving personal health information 
(PHI) that poses a risk to participants.
4.
Regulatory Concerns
a.
Any notice from regulatory bodies (e.g., FDA, EU Notified Body) recommending suspension or 
withdrawal based on emerging safety data.
5.
Individual Participant Stopping Criteria
a.
A participant may be withdrawn from the study under the following conditions:
i.
The participant experiences a serious adverse event that is possibly or definitely related to 
the device.
ii.
The investigator determines that continued participation poses a risk to the participant’s 
health or well-being
6.
Actions Upon Suspension or Termination
a.
The cause will be fully investigated by the sponsor and/or DSMB.
b.
No additional participants will be enrolled until the investigation is complete.
c.
A corrective and preventive action (CAPA) plan will be initiated.
d.
If the issue cannot be resolved or is deemed unresolvable, the study may be terminated 
permanently.

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
30
Statistical Analysis Plan 
Descriptive statistics will be used to assess the demographic variables of patients undergoing percutaneous 
ultrasound guided biopsy procedures. A combination of Chi-square analysis and Two Sample test will be used to 
determine if there is an association between the XR90 needle guidance platform and the safety and utility of biopsy 
procedures compared to the standard of care group. A stratified comparative sub-analysis may be performed if there 
are quantifiable differences in the demographic makeup of each group.  Statistical tests yielding p-values of < .05 
will be considered significant. 
The statistical analysis for the number of needle attempts follows a percentile bootstrap method because the data is 
discrete, and a normal distribution cannot be assumed. This method is a non-parametric approach that does not 
assume any specific distribution for the data to construct a 95% confidence interval. Minitab 21 will be used for 
resampling and construction of a confidence interval. Further, a randomization test will be used to determine if there 
is a significant difference between the two means.
For categorical variables, such as first attempt success rate, a Chi Square Test and Fisher’s Exact Test will be used, 
since there are two groups (Arm A (XR90), Arm B (SOC)).
Data Handling and Record Keeping 
The Principal Investigator and the sponsor will carefully monitor study procedures to protect the safety of research 
subjects, the quality of the data and the integrity of the study.  All data will be securely maintained by within the 
eCRF an electronic data capture and clinical data management tool.   Only investigators and the sponsor who have 
access to the database will access data relevant to the study.   All data will be completely de-identified and will not 
include any direct identifiers.  A separate key code will be generated in order to allow investigators to go back into 
the source data and extract further information or run down outliers in their analysis to make sure they are not 
transcription errors. Once analysis is completed, the key code will be destroyed.  
 
At the study's conclusion, the data will be stored in a repository for future use, retained and later destroyed per 
institutional policy.  All relevant research data will be archived for two years after final reporting, publication of the 
project, or post market approval.  Research data will be stored on MediView maintained servers longer if required 
by a sponsor or regulation. 
Greenlight Guru Clinical
Greenlight Guru Clinical (https://www.greenlight.guru/) will be used as the primary Electronic Data Capture and 
clinical data management tool in this study.
Greenlight Guru Clinical is designed and developed in compliance with the PIC/S Guidance, PI-011-3 Good 
Practices for Computerized Systems in Regulated “GxP” Environments, with software validation based on medical 
device software standards.

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
31
Greenlight Guru Clinical is designed to enable MediView XR Inc, and its users to comply with Good Clinical 
Practice (such as the ISO 14155:2020 standard), ICH GCP, and other industry requirements, such as FDA 21 CFR 
Part 11, HIPAA and the EU GDPR. For more information see https://www.greenlight.guru/gcp-fda-21-cfr-part-11-
and-hipaa-compliance-facilitation-statement.
All data in Greenlight Guru Clinical is collected, transferred, and stored encrypted in databases, which are hosted on 
ISO certified servers that are managed by Greenlight Guru Clinical within the European Union (Ireland and the 
Netherlands). Backups are performed continuously throughout the day. For more details on the security, backups, 
and encryption standards of Greenlight Guru Clinical, see https://www.greenlight.guru/clinical-security-and-service-
level-statement.
MediView XR, Inc. has entered a contractual agreement with Greenlight Guru Clinical which clarifies how 
Greenlight Guru Clinical complies with regulatory requirements for processing of personal identifiable information 
according to applicable regulations, such as the EU GDPR.
The focus of the data collection includes:   
•
Age
•
Gender
•
Height
•
Weight
•
BMI
•
Cancer type
•
Cancer location (including depth)
•
Video and images captured from the HoloLens without patient identifiers.  Ultrasound, CT, and fluoroscopy 
screen captures will be acquired without patient identifiers. 
•
Procedure Technical Success
•
Specimen adequate for pathological diagnosis
•
Needle Depth
•
Complications
•
Critical Structures avoided
•
Total time of participant in room
•
Time required for localization to target
•
CT to Registration time
•
Number of registration attempts
•
Time for localization
•
Skin to target time
•
Number of attempts
•
Adverse Events
Record Keeping

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
32
Investigator Records
The investigator(s) will maintain accurate, complete, and current records relating to the investigator’s participation 
in the study in compliance with 812.140(c) including:
1.
All correspondence with another investigator, an IRB, the sponsor, a monitor, or the FDA
2.
Records of receipt, use or disposition of a device.
3.
Records of each subject’s case history and exposure to the device.
Investigator Reports
The investigator will prepare and submit complete, accurate, and timely reports in compliance with 812.150(c) of 
the following:
1.
Unanticipated adverse device effects
2.
Withdrawal of IRB approval shall be reported to the sponsor within 5 working days
3.
Progress reports will be submitted to the sponsor, the monitor and the reviewing IRB at regular intervals at 
least yearly.
4.
The investigator will notify the sponsor and IRB of deviation from the investigational plan in order to 
protect the life or physical well-being of a subject in an emergency.  Notification will occur as soon as 
possible but no later than 5 working days. Prior approval by the sponsor is required for changes or 
deviations from the plan unless in the event of the described emergency.
5.
The investigator will notify the IRB and sponsor if a device is used without obtaining informed consent 
within 5 working days after the use occurs.
6.
The investigator will submit a final report of the study within 3 months of the conclusion of the study to the 
sponsor and the IRB.
Sponsor Records
The Sponsor will maintain accurate, complete, and current records relating to the study in compliance with 812.140 
(c) including:
1.
All correspondence with another investigator, an IRB, the sponsor, a monitor, or the FDA.
2.
Records of shipment and disposition. Records will include the name and address of the co-signee, type, and 
quantity of device, date of shipment, and batch number.
3.
Signed investigator agreements including the financial disclosure information required to be collected 
under 812.42 (c)
4.
Records concerning adverse device effects (both anticipated and unanticipated) and complaints.
5.
Any other records that the FDA or IRB requires to be maintained by regulation or specific requirements for 
this particular study.
Sponsor Reports
The sponsor will prepare and submit complete, accurate, and timely reports in compliance with 812.150(c) of the 
following:

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
33
1.
The sponsor will report unanticipated adverse device effects to the FDA and all reviewing IRB’s and 
participating investigators within 10 working days after the sponsor receives notice or becomes aware of 
the effect.
2.
The sponsor will notify the FDA and all reviewing IRB’s and participating investigators of any withdrawal 
of approval of the study or a part of the study by a reviewing IRB within 5 working days after receiving 
notification of the withdrawal of approval.
3.
The sponsor will notify the IRB and all investigators of any withdrawal of the FDA approval of the study 
within 5 days of receiving notification of the withdrawal of approval.
4.
The sponsor will supply a current investigator list including names and addresses of all participating 
investigators to the FDA 6 months after receiving FDA approval.
5.
The sponsor will submit progress reports to the IRB and FDA at regular intervals at least semi-annually. 
6.
The sponsor will report any request that an investigator return, repair, or otherwise dispose of any units of a 
device to the IRB and FDA.  Notices will be made within 30 working days after the request is made.
7.
The sponsor will notify the FDA of the completion or termination of the study within 30 working days of 
the completion or termination of the study.  A final report will be submitted to the FDA and IRB within 6 
months of completion or termination of the study.
8.
The sponsor will copy FDA of any report by an investigator disclosing the use of an investigational device 
without informed consent within 5 working days of receiving notice of such use.
9.
The sponsor will upon request by the reviewing IRB or FDA provide accurate complete and current 
information about any aspect of the investigation.
Determination of Unanticipated Adverse Events
Determination of Unanticipated Adverse Events(UAE) is listed below:
1.
The primary investigator or MediView staff is responsible for reporting a UAE once they become have acquired 
information that reasonably suggest an UAE has occurred.
2.
An Adverse Event form should be completed in the EDC once the primary investigator or study coordinator 
becomes aware that a possible UAE has occurred. 
3.
A UAE is defined as: A death or serious injury was or may have been attributed to a medical device, or that 
medical device was or may have been a factor in a death or serious injury, including events occurring as a result 
of:
4.
Failure Malfunction- the failure of a device to meet its performance specifications or otherwise perform as 
intended.  Performance specification include all claims made in the labeling for the device.
5.
Improper or inadequate design
6.
Manufacture Labeling or Use error
Dissemination of Data
The results of this study may be used for presentations, posters, publications, and post-market approval regulatory 
claims made by the sponsor. The publications will not contain any identifiable information that could be linked to a 
participant.  Publications, poster presentations, oral presentations, abstracts, or any other forms of publication by 
study participants will be reviewed and approved by the sponsor before submission. Publications should follow the 
cadence outlined in the clinical trial agreement. Publication or presentations by investigators or staff without sponsor 
approval is prohibited.

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
34
References
1.
Filippiadis, D., et al., Percutaneous ablation techniques for renal cell carcinoma: current status and future 
trends. Int J Hyperthermia, 2019. 36(2): p. 21-30.
2.
Ward, R.C., T.T. Healey, and D.E. Dupuy, Microwave ablation devices for interventional oncology. Expert 
Rev Med Devices, 2013. 10(2): p. 225-38.
3.
Mahnken, A.H., A.M. König, and J.H. Figiel, Current Technique and Application of Percutaneous 
Cryotherapy. Rofo, 2018. 190(9): p. 836-846.
4.
Park, B.J., et al., Augmented and Mixed Reality: Technologies for Enhancing the Future of IR. J Vasc Interv 
Radiol, 2020. 31(7): p. 1074-1082.
5.
Abi-Jaoudeh, N., et al., Clinical experience with cone-beam CT navigation for tumor ablation. J Vasc Interv 
Radiol, 2015. 26(2): p. 214-9.
6.
Hong, K. and C. Georgiades, Radiofrequency ablation: mechanism of action and devices. J Vasc Interv 
Radiol, 2010. 21(8 Suppl): p. S179-86.
7.
Luzzago, S., et al., Thermal ablation for small renal masses: Identifying the most appropriate tumor size cut-
off for predicting perioperative and oncological outcomes. Urol Oncol, 2022. 40(12): p. 537 e1-537 e9.
8.
McCarthy, C.J. and D.A. Gervais, Decision Making: Thermal Ablation Options for Small Renal Masses. 
Semin Intervent Radiol, 2017. 34(2): p. 167-175.
9.
Sebek, J., et al., Microwave ablation of lung tumors: A probabilistic approach for simulation-based treatment 
planning. Med Phys, 2021. 48(7): p. 3991-4003.
10.
Ahmed, M., et al., Principles of and advances in percutaneous ablation. Radiology, 2011. 258(2): p. 351-69.
11.
Heinrich, F., et al., HoloInjection: augmented reality support for CT-guided spinal needle injections. Healthc 
Technol Lett, 2019. 6(6): p. 165-171.
12.
Engstrand, J., et al., Stereotactic CT-Guided Percutaneous Microwave Ablation of Liver Tumors With the 
Use of High-Frequency Jet Ventilation: An Accuracy and Procedural Safety Study. AJR Am J Roentgenol, 
2017. 208(1): p. 193-200.
13.
Park, B.J., et al., Augmented reality improves procedural efficiency and reduces radiation dose for CT-guided 
lesion targeting: a phantom study using HoloLens 2. Sci Rep, 2020. 10(1): p. 18620.
14.
Liu, F., et al., A three-dimensional visualization preoperative treatment planning system for microwave 
ablation in liver cancer: a simulated experimental study. Abdom Radiol (NY), 2017. 42(6): p. 1788-1793.
15.
Al-Nimer, S., et al., 3D Holographic Guidance and Navigation for Percutaneous Ablation of Solid Tumor. J 
Vasc Interv Radiol, 2020. 31(3): p. 526-528.
16.
Gadodia, G., et al., Early Clinical Feasibility Evaluation of an Augmented Reality Platform for Guidance 
and Navigation during Percutaneous Tumor Ablation. J Vasc Interv Radiol, 2022. 33(3): p. 333-338.
17.
Ruger, C., et al., Ultrasound in augmented reality: a mixed-methods evaluation of head-mounted displays in 
image-guided interventions. Int J Comput Assist Radiol Surg, 2020. 15(11): p. 1895-1905.
18.
Gupta, S., et al., Quality improvement guidelines for percutaneous needle biopsy. J Vasc Interv Radiol, 2010. 
21(7): p. 969-75.
19.
Pua, B.B., Datta, S, Milsom, J, Gadodia, G, Evans, M, Weunski, C, Short, R. Evaluation of an Augmented 
Reality System for Ultrasound-Guided Percutaneous Procedures in Live Porcine Models. in MDIC MIXR 
Symposium. 2024. Washington, DC.

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
35
20.
Kim, E., et al., CT-guided liver biopsy with electromagnetic tracking: results from a single-center prospective 
randomized controlled trial. AJR Am J Roentgenol, 2014. 203(6): p. W715-23.
21.
Singh, A.K., et al., Core biopsy with curved needle technique. AJR Am J Roentgenol, 2008. 191(6): p. 1745-
50.
22.
Fusaglia, M., et al., A Novel Ultrasound-Based Registration for Image-Guided Laparoscopic Liver Ablation. 
Surg Innov, 2016. 23(4): p. 397-406.
23.
Mahnken, A.H. and J. Ricke. CT- and MR-guided interventions in radiology. 2009.
24.
Krasnick, B.A., et al., Tumor Ablation Using 3-Dimensional Electromagnetic-Guided Ultrasound Versus 
Standard Ultrasound in a Porcine Model. Surg Innov, 2019. 26(4): p. 420-426.
25.
Kurup, A.N., et al., Avoiding Complications in Bone and Soft Tissue Ablation. Cardiovasc Intervent Radiol, 
2017. 40(2): p. 166-176.
26.
Fonseca, A.Z., et al., Complications of radiofrequency ablation of hepatic tumors: Frequency and risk 
factors. World J Hepatol, 2014. 6(3): p. 107-13.
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Kong, W.T., et al., Major complications after radiofrequency ablation for liver tumors: analysis of 255 
patients. World J Gastroenterol, 2009. 15(21): p. 2651-6.
Appendices 
To be attached as separate documents
LBL-0022
MediView XR90 User Manual
LBL-0026
XR90 HFV Needle Based Proceduralist Powerpoint
LBL-0028
CT Acquisition Protocol & MediView Triangle Template Instructions for Use
LBL-0031
XR90 EM Probe Bracket Instructions for Use
LBL-0032
XR90 Field Generator Brackets Instructions for Use
LBL-0033
XR90 Registration Markers Instructions for Use
MKT-0012 
XR90 Training Video
REC-XXX
XR90 Post Procedure Operator Survey
PDPROJ-4.0 BRA
Benefit/Risk Analysis, XR90

Clinical Protocol Form
Document Title
Document Description
Version No.
TP-172
Clinical Evaluation of an Intra-procedural 3D Needle 
Guidance Platform for Soft Tissue Tumors or Organs 
Requiring Percutaneous Biopsy as an Adjunct to Standard 
Image Guidance 
3
05/02/2025
36
Versions
Version 0
Initial Release
Version 1
Updates to expected study duration, TRE calculations, 
added power analysis for sample size justification and 
other minor updates
Version 2
Endpoints and eligibility criteria updated. Power 
analysis and sample size adjusted. Minor formatting 
and grammar changes.
Version 3
Justification for power analysis and sample 
calculations added.  Stratification criteria removed. 
Language added to clarify device additions, data 
collection and randomization procedures. Inclusion and 
exclusion criteria updated.  Title updated to reflect new 
inclusion criteria. Grammar and formatting updated 
throughout the document.