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Trial registered on ANZCTR


Registration number
ACTRN12620001194954
Ethics application status
Approved
Date submitted
11/09/2020
Date registered
10/11/2020
Date last updated
10/11/2020
Date data sharing statement initially provided
10/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of the GPX Embolic Device in Patients Requiring Embolization
Scientific title
A Feasibility Study of the GPX Embolic Device
Secondary ID [1] 302274 0
Fluidx Medical Technology, LLC protocol number: RF-0032
Universal Trial Number (UTN)
U1111-1257-9629
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Varicocele 319005 0
Type II endoleaks 319006 0
Portal vein requiring pre-operative embolization 319007 0
Renal or hepatic tumor requiring pre-operative embolization 319008 0
Vascular malformation suitable for embolization with a liquid agent 319009 0
Renal angiomyolipoma (AML) requiring embolization 319010 0
Need for coil-assisted branch artery embolization pre-endovascular aneurysm repair (EVAR) 319011 0
Pelvic congestion syndrome requiring ovarian vein embolization 319012 0
Condition category
Condition code
Renal and Urogenital 316971 316971 0 0
Normal development and function of male and female renal and urogenital system
Cardiovascular 316978 316978 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 316979 316979 0 0
Normal development and function of the cardiovascular system
Renal and Urogenital 316980 316980 0 0
Other renal and urogenital disorders
Cancer 317320 317320 0 0
Kidney
Cancer 317321 317321 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves blood vessel embolization, under fluoroscopic guidance, using the GPX Embolic Device.

Participants will undergo a transcatheter embolization procedure, performed by a medical doctor (i.e., an interventional radiologist or vascular surgeon) in a hospital setting typically in under one hour, where GPX Embolic Device will be injected to a blood vessel needing to be treated. Once deployed in the subject's blood vessel, the GPX Embolic device will solidify to a gel-like solid within a few minutes. GPX Embolic Device will then remain in the patient throughout their lifetime. GPX Embolic Device will only be delivered to the subject once, and only up to 3mL of GPX Embolic Device will be administered. GPX administration will be personalised to each patient based on their health condition and their doctor's treatment decisions.

Subjects will be contacted for 7-day and 30-day follow-ups. The patient may undergo an additional imaging procedure along with their final follow-up to view the GPX Embolic Device and affected anatomy.

Participants will receive a Patient Information Sheet prior to consenting to the study informing them of the procedure and study. Physicians and staff involved in the study will be trained on the use of the device and on the study protocol and procedures. They will receive the study protocol, Investigator's Brochure, and other study materials (e.g., Case Report Forms) to enable them to enroll subjects and follow them through the study period.
Intervention code [1] 318568 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325087 0
Complete Occlusion: Complete occlusion of the target embolization site(s) as confirmed by the Investigator via imaging assessment during the procedure (assessed at 1-minute intervals post-deployment until occlusion or 10 minutes).
Timepoint [1] 325087 0
Assessed at 1-minute intervals post-deployment until occlusion or 10 minutes
Primary outcome [2] 325088 0
Incidence of Device-Related Serious Adverse Events (SAE): During the procedure and through follow-up clinical evaluation at 30 days or at time of resection if earlier.
Timepoint [2] 325088 0
At 30 days or at time of resection if earlier
Secondary outcome [1] 386814 0
Complete Occlusion at Imaging Visit: Successful occlusion of the target embolization site(s) at the imaging visit (if conducted based on standard of care) as confirmed by the Investigator via imaging assessment.
Timepoint [1] 386814 0
30 (-5/+30) days in conjuction with the subject's final follow-up
Secondary outcome [2] 386815 0
Time to Occlusion: Time to achieve occlusion of the target embolization site(s) as confirmed by the Investigator via imaging assessment during the procedure.
Timepoint [2] 386815 0
Assessed at 1-minute intervals post-deployment until occlusion or 10 minutes
Secondary outcome [3] 386816 0
Incomplete Occlusion: Clinically relevant incomplete occlusion of the target embolization site(s) as confirmed by Investigator via imaging assessment during the procedure.
Timepoint [3] 386816 0
Assessed at 1-minute intervals post-deployment until occlusion or 10 minutes
Secondary outcome [4] 386817 0
Non-Target Embolization: Clinically relevant non-target embolization of the study material as confirmed by Investigator via imaging assessment during the procedure.
Timepoint [4] 386817 0
Assessed at 1-minute intervals post-deployment until occlusion or 10 minutes
Secondary outcome [5] 386818 0
Recanalization: Clinically relevant recanalization of the target embolization site(s) at the imaging visit (if conducted) as confirmed by the Investigator via imaging assessment.
Timepoint [5] 386818 0
30 (-5/+30) days in conjuction with the subject's final follow-up
Secondary outcome [6] 386819 0
Device-Related Adverse Events (AE): Device-related AEs during procedure and through the required clinical evaluations.

Note: AEs are recorded in study Case Report Forms. All AEs are recorded, including but not limited to events reported by the subject or reported in response to an open question by the principal investigator or member of the investigation team.
Timepoint [6] 386819 0
30 days following the procedure
Secondary outcome [7] 386820 0
Composite secondary outcome related to Investigator Satisfaction: Device preparation, material delivery, material visualization and overall satisfaction as measured on Post-Procedure Physician Questionnaire).
Timepoint [7] 386820 0
Post-procedure
Secondary outcome [8] 386821 0
Volume of GPX Embolic Material Used: Mean volume of GPX used during the procedure.

Note: GPX volume details are recorded on Procedure Case Report Forms. The amount of volume delivered is a function of catheter priming volume and embolic material remaining in the syringe.
Timepoint [8] 386821 0
During the procedure

Eligibility
Key inclusion criteria
• Subject presenting with varicocele, Type II endoleaks, portal vein requiring pre-operative embolization, renal or hepatic tumor requiring pre-operative embolization, vascular malformation suitable for embolization with a liquid agent, renal angiomyolipoma (AML) requiring embolization, need for coil-assisted branch artery embolization pre-endovascular aneurysm repair (EVAR), pelvic congestion syndrome requiring ovarian vein embolization.
• Subject is greater than or equal to 18 years of age with an expected lifespan sufficient to allow for completion of study procedure and follow-up visit, if appropriate based on standard of care
• Subject has been informed of the nature of the study and agrees to its provisions and has provided informed written consent (signed the Participant Information Sheet and Consent Form).
• Subject must be willing and able to comply with protocol requirements, including all procedures, clinical evaluations, and follow-up visits, if appropriate based on standard of care.
• Subject has vascular anatomy that meets the requirements of the IFU.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Subject unwilling or unable to consent.
• Subject’s access vessel(s) preclude safe insertion of delivery catheter or catheter is unable to be advanced to targeted location.
• Subject has a known allergy or hypersensitivity to contrast media that cannot be adequately medicated.
• Subject who is pregnant, breastfeeding, or intending to father children.
• Subject who is judged unable or unwilling to comply with required follow up visit (if follow-up visit is appropriate based on standard of care).
• Subject with unresolved systemic infection.
• Subject’s required pre-operative laboratory tests and/or physical examination indicate abnormal results, which, in the opinion of the Investigator, would clinically interfere with the study endpoints.
• Subject has another medical condition which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, may confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up clinical evaluations.
• Subject is participating in another investigational research study investigating a device, drug, or procedure that has not completed the study treatment or that clinically interferes with these study endpoints (Post-approval registries are allowed as long as the Investigator determines there is no clinical interference with study endpoints).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22975 0
New Zealand
State/province [1] 22975 0
Auckland
Country [2] 22976 0
New Zealand
State/province [2] 22976 0
Canterbury

Funding & Sponsors
Funding source category [1] 306701 0
Commercial sector/Industry
Name [1] 306701 0
Fluidx Medical Technology, LLC
Address [1] 306701 0
2500 South State Street; Suite D246
Salt Lake City, Utah 84115
USA
Country [1] 306701 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Fluidx Medical Technology, LLC
Address
2500 South State Street; Suite D246
Salt Lake City, Utah 84115
USA
Country
United States of America
Secondary sponsor category [1] 307249 0
None
Name [1] 307249 0
Address [1] 307249 0
Country [1] 307249 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306872 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 306872 0
Northern A Health and Disability Ethics Committee
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
New Zealand
Ethics committee country [1] 306872 0
New Zealand
Date submitted for ethics approval [1] 306872 0
Approval date [1] 306872 0
20/08/2020
Ethics approval number [1] 306872 0

Summary
Brief summary
This study is a single-arm, open label, non-randomized, prospective, first in human (FIH) feasibility study evaluating the use of the GPX Embolic Device in the peripheral vasculature. The primary objectives for this study are to evaluate safety and early indicators of performance for the GPX Embolic Device and to support the development of a pivotal clinical trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105298 0
A/Prof Andrew Holden
Address 105298 0
Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
Country 105298 0
New Zealand
Phone 105298 0
+6493797440
Fax 105298 0
Email 105298 0
andrewh@adhb.govt.nz
Contact person for public queries
Name 105299 0
Mr Christopher Phillips
Address 105299 0
Fluidx Medical Technology, LLC
2500 South State Street; Suite D246
Salt Lake City, Utah 84115
United States of America
Country 105299 0
United States of America
Phone 105299 0
+18016131647
Fax 105299 0
Email 105299 0
christopher.phillips@fluidxmedical.com
Contact person for scientific queries
Name 105300 0
A/Prof Andrew Holden
Address 105300 0
Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
Country 105300 0
New Zealand
Phone 105300 0
+6493797440
Fax 105300 0
Email 105300 0
andrewh@adhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 9131 0
Informed consent form
Citation [1] 9131 0
Link [1] 9131 0
Email [1] 9131 0
Other [1] 9131 0
Type [2] 9132 0
Ethical approval
Citation [2] 9132 0
Link [2] 9132 0
Email [2] 9132 0
Other [2] 9132 0
Summary results
No Results