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Trial registered on ANZCTR


Registration number
ACTRN12619000536167
Ethics application status
Approved
Date submitted
28/03/2019
Date registered
4/04/2019
Date last updated
3/04/2024
Date data sharing statement initially provided
4/04/2019
Date results information initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Instylla Hydrogel Embolic System First In Human Study For Patients Requiring Vascular Embolization Alone or in the Pre-operative Setting for Treatment of Malignant and Benign Hypervascular Tumors, and Select Non-Traumatic End-Organ Infarct
Scientific title
A Prospective, Single-arm, Multicenter Study to Evaluate the Safety and Performance of the Instylla Hydrogel Embolic System (HES) For Patients Requiring Vascular Embolization Alone or in the Pre-operative Setting for Treatment of Malignant and Benign Hypervascular Tumors, and Select Non-Traumatic End-Organ Infarct.
Secondary ID [1] 297824 0
INY-P-19-001
Universal Trial Number (UTN)
U1111-1230-7747
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients Requiring Vascular Embolization Alone for Treatment of Malignant Tumors 312192 0
Patients Requiring Vascular Embolization in the Pre-operative Setting for Treatment of Malignant Tumors 312193 0
Patients Requiring Vascular Embolization Alone for Treatment of Benign Hypervascular Tumors 312194 0
Patients Requiring Vascular Embolization in the Pre-operative Setting for Treatment of Benign Hypervascular Tumors 312195 0
Patients Requiring Vascular Embolization for Select Non-Traumatic End-Organ Infarct 312196 0
Condition category
Condition code
Cancer 310741 310741 0 0
Liver
Cardiovascular 310785 310785 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cancer 310799 310799 0 0
Bone
Cancer 310800 310800 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Instylla Hydrogel Embolic System (HES) including Instylla Delivery Kit and Instylla Microcatheter.
This involvement for the patient is the same procedures, activities and processes used for standard vascular embolization procedures.
Subjects will be treated within this protocol by an interventionalist with substantial prior experience with vascular embolization procedure.
The mode of delivery will be performed face to face and the location will be at the hospital.
The number of interventions that will be delivered will be one time and possible more over the 90 day follow-up period. The procedure will take about the same time as a standard embolic procedure (about 30 minutes to an hour).
The interventionalist or oncologist will decide if more procedures are administered.
Intervention code [1] 314064 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319589 0
Incidence of serious device and serious procedure-related adverse events and non target embolization. Events will be reviewed by an Independent Medical Monitor. (composite endpoint)
There are no known unique risks associated with the Instylla HES.
Throughout the duration of the study, subjects will be clinically evaluated (imaging and blood lab tests) and assessed for adverse events using the grading of the NCI Common Terminology Criteria for Adverse Events (CTCAE Version 5.0). Severity of complications will be further classified in accordance with Society of Interventional Radiology (SIR) guidelines.
Timepoint [1] 319589 0
90 days post-embolization
Secondary outcome [1] 368805 0
Technical success of achieving embolization demonstrated by post procedure angiography.
Timepoint [1] 368805 0
Immediately after embolisation procedure

Eligibility
Key inclusion criteria
1. Male or female patients age greater than or equal to 18 years old
2. Embolization of hypervascular lesion is clinically indicated
3. Expected life expectancy greater than or equal to 6 months after embolization
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Ongoing adverse effect that may confound the evaluation of the Instylla HES
2. Pregnant or breast-feeding, or females planning on becoming pregnant within the next 6 month
3. The patient has other concurrent conditions that in the opinion of the Investigator would be unlikely to receive clinical benefit from the study procedure or participation in the study may compromise patient safety or study objectives (including but not limited to ongoing infection, renal dysfunction, morbid obesity)

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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2019
Actual
22/10/2019
Date of last participant enrolment
Anticipated
Actual
19/05/2020
Date of last data collection
Anticipated
Actual
5/08/2020
Sample size
Target
15
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 302348 0
Commercial sector/Industry
Name [1] 302348 0
Instylla Inc
Country [1] 302348 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Instylla Inc
Address
201 Burlington Road
Bedford, MA 01730
Country
United States of America
Secondary sponsor category [1] 302234 0
Commercial sector/Industry
Name [1] 302234 0
Five Corners Pty Ltd
Address [1] 302234 0
13/76 Reserve Road, Artarmon NSW 2064
Country [1] 302234 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303022 0
Alfred Hospital Ethics Committee https://www.alfredhealth.org.au/research/ethics-research-governance
Ethics committee address [1] 303022 0
55 Commercial Road
Melbourne
Victoria
3004
Ethics committee country [1] 303022 0
Australia
Date submitted for ethics approval [1] 303022 0
25/03/2019
Approval date [1] 303022 0
15/05/2019
Ethics approval number [1] 303022 0

Summary
Brief summary
This study will evaluate the safety and performance of the Instylla Hydrogel Embolic System for patients requiring vascular embolisation alone or vascular embolisation for treatment of Malignant and Benign Hypervascular Tumors or non-traumatic end-organ infarct

Who is it for?
You may be eligible to join this study if you are aged 18 and above and are requiring vascular embolisation alone or vascular embolisation for treatment of Malignant and, or Benign Hypervascular Tumors, or non-traumatic end-organ infarct.

Study details
All participants will receive vascular embolisation using the Instylla Hydrogel Embolic System (HES) including Instylla Delivery Kit and Instylla Microcatheter. Safety and performance of the HES will be assessed using using the grading of the NCI Common Terminology Criteria for Adverse Events (CTCAE Version 5.0). Severity of complications will be further classified in accordance with Society of Interventional Radiology (SIR) guidelines. for up to 90 days post-embolisation.

This study will also allow a greater understanding of whether HES can be used to embolise vascular tumours or organs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92198 0
Dr Gerard Goh
Address 92198 0
Radiology Dept.
The Alfred
55 Commercial Road, Melbourne Vic. 3004
Vic. 3004
Country 92198 0
Australia
Phone 92198 0
+61 (0)3 9076 3630
Fax 92198 0
Email 92198 0
[email protected]
Contact person for public queries
Name 92199 0
FIH Study contact
Address 92199 0
Instylla, Inc. 201 Burlington Road Bedford, MA 01730
Country 92199 0
United States of America
Phone 92199 0
+1 781 790 4863
Fax 92199 0
Email 92199 0
[email protected]
Contact person for scientific queries
Name 92200 0
FIH Study contact
Address 92200 0
Instylla, Inc. 201 Burlington Road Bedford, MA 01730
Country 92200 0
United States of America
Phone 92200 0
+1 781 790 4863
Fax 92200 0
Email 92200 0
[email protected]

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?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes JVascIntervRadiol2022;33:660–667. Published March ... [More Details] 377285-(Uploaded-13-03-2024-18-03-59)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.