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Trial Review
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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
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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.
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Secondary ID [1]
297824
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INY-P-19-001
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Universal Trial Number (UTN)
U1111-1230-7747
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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 Vascular Embolization Alone for Treatment of Malignant Tumors
312192
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Patients Requiring Vascular Embolization in the Pre-operative Setting for Treatment of Malignant Tumors
312193
0
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Patients Requiring Vascular Embolization Alone for Treatment of Benign Hypervascular Tumors
312194
0
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Patients Requiring Vascular Embolization in the Pre-operative Setting for Treatment of Benign Hypervascular Tumors
312195
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Patients Requiring Vascular Embolization for Select Non-Traumatic End-Organ Infarct
312196
0
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Condition category
Condition code
Cancer
310741
310741
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0
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Liver
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Cardiovascular
310785
310785
0
0
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Diseases of the vasculature and circulation including the lymphatic system
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Cancer
310799
310799
0
0
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Bone
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Cancer
310800
310800
0
0
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Kidney
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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 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.
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Intervention code [1]
314064
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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]
319589
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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]
319589
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Timepoint [1]
319589
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90 days post-embolization
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Secondary outcome [1]
368805
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Technical success of achieving embolization demonstrated by post procedure angiography.
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Assessment method [1]
368805
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Timepoint [1]
368805
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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. Embolization of hypervascular lesion is clinically indicated
3. Expected life expectancy greater than or equal to 6 months after embolization
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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 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)
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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
Completed
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Date of first participant enrolment
Anticipated
1/07/2019
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Actual
22/10/2019
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Date of last participant enrolment
Anticipated
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Actual
19/05/2020
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Date of last data collection
Anticipated
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Actual
5/08/2020
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Sample size
Target
15
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Accrual to date
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Final
8
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
302348
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Commercial sector/Industry
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Name [1]
302348
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Instylla Inc
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Address [1]
302348
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204 Second Ave, Lower Level
Waltham, MA 02451
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Country [1]
302348
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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]
302234
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Commercial sector/Industry
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Name [1]
302234
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Five Corners Pty Ltd
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Address [1]
302234
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13/76 Reserve Road, Artarmon NSW 2064
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Country [1]
302234
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303022
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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]
303022
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55 Commercial Road
Melbourne
Victoria
3004
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Ethics committee country [1]
303022
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Australia
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Date submitted for ethics approval [1]
303022
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25/03/2019
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Approval date [1]
303022
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15/05/2019
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Ethics approval number [1]
303022
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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 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.
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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
92198
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Dr Gerard Goh
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Address
92198
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Radiology Dept.
The Alfred
55 Commercial Road, Melbourne Vic. 3004
Vic. 3004
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Country
92198
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Australia
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Phone
92198
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+61 (0)3 9076 3630
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Fax
92198
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Email
92198
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[email protected]
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Contact person for public queries
Name
92199
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Ms FIH Study contact
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Address
92199
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Instylla, Inc. 201 Burlington Road Bedford, MA 01730
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Country
92199
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United States of America
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Phone
92199
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+1 781 790 4863
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Fax
92199
0
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Email
92199
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[email protected]
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Contact person for scientific queries
Name
92200
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Ms FIH Study contact
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Address
92200
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Instylla, Inc. 201 Burlington Road Bedford, MA 01730
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Country
92200
0
United States of America
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Phone
92200
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+1 781 790 4863
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Fax
92200
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Email
92200
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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
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
JVascIntervRadiol2022;33:660–667. Published March ...
[
More Details
]
377285-(Uploaded-13-03-2024-18-03-59)-Journal results publication.pdf
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No additional documents have been identified.
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