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Trial registered on ANZCTR
Registration number
ACTRN12620000349943
Ethics application status
Approved
Date submitted
6/03/2020
Date registered
12/03/2020
Date last updated
3/04/2024
Date data sharing statement initially provided
12/03/2020
Date results information initially provided
3/04/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Instylla Hydrogel Embolic System Pilot Study For Patients Requiring Transcatheter Embolization of Vascular Bleeds
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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
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Secondary ID [1]
300733
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INY-P-20-002
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Universal Trial Number (UTN)
U1111-1249-3159
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Patients Requiring Transcatheter Embolization of Vascular Bleeds
316556
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Condition category
Condition code
Emergency medicine
314794
314794
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0
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Other emergency care
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
317056
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Treatment: Devices
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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30 days post-embolization
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Secondary outcome [1]
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Technical success of achieving embolization demonstrated by post procedure angiography.
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Assessment method [1]
380972
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Timepoint [1]
380972
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Immediately after embolisation procedure
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data analysis is complete
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Reason for early stopping/withdrawal
Other reasons/comments
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Other reasons
The study was prematurely terminated because of the situation that arose after the COVID-19 pandemic hit. Site locations were closed, and clinical studies put on hold worldwide. Once sites were opened and studies allowed, Instylla Inc. decided to investigate Instylla HES in a large-scale clinical investigation in other geographical locations.
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Date of first participant enrolment
Anticipated
15/02/2021
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Actual
4/06/2021
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Date of last participant enrolment
Anticipated
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Actual
8/11/2021
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Date of last data collection
Anticipated
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Actual
8/12/2021
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Sample size
Target
15
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Accrual to date
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Final
2
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
305184
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Commercial sector/Industry
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Name [1]
305184
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Instylla Inc
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Address [1]
305184
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201 Burlington Road Bedford, MA 01730
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Country [1]
305184
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Instylla Inc
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Address
201 Burlington Road Bedford, MA 01730
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Country
United States of America
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Secondary sponsor category [1]
305539
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Commercial sector/Industry
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Name [1]
305539
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Avania Pty Ltd
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Address [1]
305539
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13/76 Reserve Road, Artarmon NSW 2064
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Country [1]
305539
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305540
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Alfred Hospital Ethics Committee https://www.alfredhealth.org.au/research/ethics-research-governance
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Ethics committee address [1]
305540
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55 Commercial Road Melbourne Victoria 3004
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Ethics committee country [1]
305540
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Australia
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Date submitted for ethics approval [1]
305540
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23/03/2020
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Approval date [1]
305540
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11/06/2020
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Ethics approval number [1]
305540
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
100722
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Dr Gerard Goh
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Address
100722
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Radiology Dept. The Alfred 55 Commercial Road, Melbourne Vic. 3004
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Country
100722
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Australia
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Phone
100722
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+61 3 9076 3630
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Fax
100722
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Email
100722
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[email protected]
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Contact person for public queries
Name
100723
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Ms Nicole Rissman
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Address
100723
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201 Burlington Road Bedford, MA 01730
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Country
100723
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United States of America
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Phone
100723
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+1 781 790 4860
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Fax
100723
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Email
100723
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[email protected]
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Contact person for scientific queries
Name
100724
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Ms Nicole Rissman
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Address
100724
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201 Burlington Road Bedford, MA 01730
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Country
100724
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United States of America
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Phone
100724
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+1 781 790 4860
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Fax
100724
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Email
100724
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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