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Trial registered on ANZCTR


Registration number
ACTRN12620000349943p
Ethics application status
Not yet submitted
Date submitted
6/03/2020
Date registered
12/03/2020
Date last updated
12/03/2020
Date data sharing statement initially provided
12/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Instylla Hydrogel Embolic System Pilot Study For Patients Requiring Transcatheter Embolization of Vascular Bleeds
Scientific title
A Prospective, Non-Randomized Single-Arm Pilot Study to Assess the Safety and Effectiveness of Instylla Hydrogel Embolic System (HES) For Transcatheter Embolization of Vascular Bleeds
Secondary ID [1] 300733 0
INY-P-20-002
Universal Trial Number (UTN)
U1111-1249-3159
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients Requiring Transcatheter Embolization of Vascular Bleeds 316556 0
Condition category
Condition code
Emergency medicine 314794 314794 0 0
Other emergency care

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 30 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 will decide if more procedures are administered.
Intervention code [1] 317056 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323158 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] 323158 0
30 days post-embolization
Secondary outcome [1] 380972 0
Technical success of achieving embolization demonstrated by post procedure angiography.
Timepoint [1] 380972 0
Immediately after embolisation procedure

Eligibility
Key inclusion criteria
1. Male or female patients age greater than or equal to 18 years old
2. Transcatheter vascular embolization of vascular bleeds is clinically indicated
3. Positive angiographic findings of bleeding
Minimum age
18 Years
Maximum age
No limit
Gender
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 females
3. The patient has other concurrent conditions or known history 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, 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
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 in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 305184 0
Commercial sector/Industry
Name [1] 305184 0
Instylla Inc
Address [1] 305184 0
204 Second Ave, Lower Level Waltham, MA 02451
Country [1] 305184 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Instylla Inc
Address
204 Second Ave, Lower Level Waltham, MA 02451
Country
United States of America
Secondary sponsor category [1] 305539 0
Commercial sector/Industry
Name [1] 305539 0
Five Corners Pty Ltd
Address [1] 305539 0
13/76 Reserve Road, Artarmon NSW 2064
Country [1] 305539 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 305540 0
Alfred Hospital Ethics Committee https://www.alfredhealth.org.au/research/ethics-research-governance
Ethics committee address [1] 305540 0
55 Commercial Road Melbourne Victoria 3004
Ethics committee country [1] 305540 0
Australia
Date submitted for ethics approval [1] 305540 0
23/03/2020
Approval date [1] 305540 0
Ethics approval number [1] 305540 0

Summary
Brief summary
This study will evaluate the safety and performance of the Instylla Hydrogel Embolic System for patients requiring vascular embolisation for treatment of bleeds.

Who is it for?
You may be eligible to join this study if you are aged 18 and above and are requiring vascular embolisation for treatment of bleeds.

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 30 days post-embolisation.

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

Contacts
Principal investigator
Name 100722 0
Dr Gerard Goh
Address 100722 0
Radiology Dept. The Alfred 55 Commercial Road, Melbourne Vic. 3004
Country 100722 0
Australia
Phone 100722 0
+61 3 9076 3630
Fax 100722 0
Email 100722 0
g.goh@alfred.org.au
Contact person for public queries
Name 100723 0
Ms Nicole Rissman
Address 100723 0
Instylla, Inc. 204 Second Ave, Lower Level Waltham, MA 02451
Country 100723 0
United States of America
Phone 100723 0
+1 781 790 4860
Fax 100723 0
Email 100723 0
nicoler@instylla.com
Contact person for scientific queries
Name 100724 0
Ms Nicole Rissman
Address 100724 0
Instylla, Inc. 204 Second Ave, Lower Level Waltham, MA 02451
Country 100724 0
United States of America
Phone 100724 0
+1 781 790 4860
Fax 100724 0
Email 100724 0
nicoler@instylla.com

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 other documents available
Summary results
No Results