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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04523350




Registration number
NCT04523350
Ethics application status
Date submitted
17/08/2020
Date registered
21/08/2020
Date last updated
29/05/2024

Titles & IDs
Public title
Instylla HES Hypervascular Tumor Pivotal Study
Scientific title
Randomized Multi-Center, Subject and Evaluator Blinded, Parallel-Group Study to Evaluate the Safety and Effectiveness of the Instylla Hydrogel Embolic System (HES) Compared With Standard of Care Transcatheter Arterial Embolization (TAE) / Transcatheter Arterial Chemoembolization (cTACE) for Vascular Occlusion of Hypervascular Tumors; A Pivotal Study
Secondary ID [1] 0 0
INY-P-20-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Instylla HES
Other interventions - TAE or cTACE

Experimental: Instylla HES -

Active comparator: Control - TAE or cTACE


Treatment: Devices: Instylla HES
Instylla HES is a novel liquid embolic made of primarily water and polyethylene glycol (PEG)

Other interventions: TAE or cTACE
Bland TAE or cTACE
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Effectiveness Endpoint: Delivery of the embolic agent to the index tumor feeding vessel with stasis of flow as determined by an independent radiologist via comparison of the pre and final post procedure images
Timepoint [1] 0 0
Immediately post-embolization procedure
Primary outcome [2] 0 0
Primary Safety Endpoint: Freedom from major adverse events through 30 days post-index procedure
Timepoint [2] 0 0
30 days post-embolization procedure

Eligibility
Key inclusion criteria
1. Male or female subjects age = 22 years old
2. Subjects with confirmed finding of hypervascular tumor on CT and/or MRI for whom TAE or cTACE is medically indicated, including but not limited to:

1. Subjects with unresectable primary or metastatic hepatic cancer
2. Subjects with primary, metastatic or benign renal tumors
3. Subjects with bone metastases
4. Subjects with adrenal tumors
5. Subjects with other hypervascular tumors
3. Subjects with at least one target lesion that is well-delineated such that, in the Investigator's opinion, the lesion can be measured in at least one dimension as 1 cm or more, suitable for remeasurement, and demonstrating definitive arterial enhancement (Note: Pre-operative tumors do not need to meet this criterion.)
4. Subjects with at least one target vessel = 5mm and Instylla HES can be delivered to the target vessel(s).
5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2 (PS 0-1 for metastatic disease)
6. Subject or authorized representative have been informed of the nature of the study and has provided written informed consent approved by the appropriate local Ethics Committee/Institutional Review Board and agrees to comply with all protocol specified follow-up appointments.
7. Expected life expectancy = 6 months after Index embolization
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Embolization for lesions other than hypervascular tumors such as arteriovenous malformations.
2. It is anticipated that not all target vessels requiring embolization during the index procedure can be embolized with either HES alone or the SOC embolization agent as assigned.
3. Undergoing radioembolization or DEB-TACE for Index Procedure
4. Undergoing a planned secondary procedure the same day as the Index Procedure
5. Requires TAE/cTACE for liver tumors via extrahepatic collateral artery(ies)
6. Prior radioembolization of the target tumor lesion/vascular bed within 30 days of the Index Procedure.
7. For subjects with HCC or undergoing embolization to the liver: Child-Pugh Class C or presence of complete portal vein thrombosis.
8. Tumor lesions > 8 cm in diameter (in one direction) or >50% tumor volume burden of the target organ
9. If subject was treated with Avastin, last dose is within 4 weeks of the planned procedure.
10. Known severe atheromatosis or vascular anatomy that precludes catheterization
11. Presence of bilioenteric anastomoses and/or prior biliary stenting/drainage or any violation of the biliary sphincter, including sphincterotomy for embolization of liver tumors
12. Target lesion supplied by the pulmonary artery, coronary artery, or cerebral or cerebellar artery (requiring embolization of these arteries) or the artery to be embolized has connections to these arteries via a collateral pathway
13. Known allergies (based on history) to PEG, ferrous compounds, tert Butyl Hydroperoxide, contrast media or procedural sedatives/anesthetics that is not amenable to pre-medication
14. Uncorrectable impaired clotting: Platelet count <30,000/µL or International Normalized Ratio (INR) > 1.5
15. Serum creatinine > 2 mg/dL
16. Serum bilirubin level > 3 mg/dL
17. Serum albumin < 2.5 g/dL
18. Any contraindication to angiography or embolization protocol utilized at treating institution.
19. Pregnant or breast-feeding or females planning on becoming pregnant with the next 3 months (women of child-bearing potential must undergo a pregnancy test performed in accordance with local institutional requirements).
20. Other concurrent conditions including an ongoing adverse effect or complication of prior therapy or adverse drug reactions, that in the opinion of the Investigator or Clinical Events Committee, would be unlikely to receive clinical benefit from the study procedure or participation in the study may compromise subject safety or study objectives (including but not limited to ongoing acute infection, renal dysfunction, morbid obesity, severe cardiac disease).
21. Enrollment in a concurrent study in which the study treatment may confound the evaluation of the study device

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Instylla, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To determine whether Instylla HES has the ability to effectively embolize targeted arterial segments of hypervascular tumors as well as (i.e., is non-inferior to) standard of care (SOC) transarterial embolization/conventional transarterial chemoembolization, while resulting in an acceptable risk of device and procedure-related serious adverse events.
Trial website
https://clinicaltrials.gov/study/NCT04523350
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Nadine Abi-Jaoudeh, M.D.
Address 0 0
University of California, Irvine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
1 781-790-4860
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04523350