Hypervascular TumorsNCT04523350
Instylla HES Hypervascular Tumor Pivotal Study
A study testing Instylla HES and TAE or cTACE in people with Hypervascular Tumors, run by Instylla, Inc. at 15 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Hypervascular Tumors
- What is being tested?
- Instylla HES and TAE or cTACE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 5 Mar 2021to 19 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects age ≥ 22 years old
- 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:
- Subjects with unresectable primary or metastatic hepatic cancer
- Subjects with primary, metastatic or benign renal tumors
- Subjects with bone metastases
- Subjects with adrenal tumors
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- Subjects with other hypervascular tumors
- 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.)
- Subjects with at least one target vessel ≤ 5mm and Instylla HES can be delivered to the target vessel(s).
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2 (PS 0-1 for metastatic disease)
- 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.
- Expected life expectancy ≥ 6 months after Index embolization
Who cannot join
- Embolization for lesions other than hypervascular tumors such as arteriovenous malformations.
- 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.
- Undergoing radioembolization or DEB-TACE for Index Procedure
- Undergoing a planned secondary procedure the same day as the Index Procedure
- Requires TAE/cTACE for liver tumors via extrahepatic collateral artery(ies)
- Prior radioembolization of the target tumor lesion/vascular bed within 30 days of the Index Procedure.
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- For subjects with HCC or undergoing embolization to the liver: Child-Pugh Class C or presence of complete portal vein thrombosis.
- Tumor lesions > 8 cm in diameter (in one direction) or >50% tumor volume burden of the target organ
- If subject was treated with Avastin, last dose is within 4 weeks of the planned procedure.
- Known severe atheromatosis or vascular anatomy that precludes catheterization
- Presence of bilioenteric anastomoses and/or prior biliary stenting/drainage or any violation of the biliary sphincter, including sphincterotomy for embolization of liver tumors
- 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
- 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
- Uncorrectable impaired clotting: Platelet count <30,000/µL or International Normalized Ratio (INR) > 1.5
- Serum creatinine > 2 mg/dL
- Serum bilirubin level > 3 mg/dL
- Serum albumin < 2.5 g/dL
- Any contraindication to angiography or embolization protocol utilized at treating institution.
- 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).
- 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).
- Enrollment in a concurrent study in which the study treatment may confound the evaluation of the study device
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States12 sites
UAB Hospital
Birmingham, Alabama, 35233
Boston Medical Center
Boston, Massachusetts, 02118
Charlotte Radiology
Charlotte, North Carolina, 28202
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017
Summit Health
Florham Park, New Jersey, 07932
University of California, Irvine
Irvine, California, 92697- 7600
Central Arkansas Radiation Therapy Institute, Inc.
Little Rock, Arkansas, 72205
Memorial Health Services
Long Beach, California, 92708
New York and Presbyterian Hospital (Cornell/Weill Medical College)
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6061
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Olive View-UCLA Education & Research Institute
Sylmar, California, 91342-1495
Canada3 sites
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
Mount Sinai
Toronto, Ontario, M5G 1Z5
Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
Official 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
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.
- Conditions
- Hypervascular Tumors
- Being tested
- Instylla HES, TAE or cTACE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instylla HESDevice
Instylla HES is a novel liquid embolic made of primarily water and polyethylene glycol (PEG)
TAE or cTACEOther
Also called Control
Bland TAE or cTACE
| Study group | Role | What they receive |
|---|---|---|
| Instylla HES | Experimental | Not described Receives: Device: Instylla HES |
| Control | Active comparator | TAE or cTACE Receives: Other: TAE or cTACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Stasis of flow defined as absence of contrast flow within the targeted tumor feeding vessel
Measured: Immediately post-embolization procedure
Primary Safety Endpoint: Freedom From Major Adverse Events Through 30 Days Post-index Procedure
Freedom from major adverse events through 30 days post-index procedure compared to a literature derived performance goal
Measured: 30 days post-embolization procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start5 Mar 2021
- Primary completion1 May 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypervascular TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instylla, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nadine Abi-Jaoudeh, M.D., Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523350
- Sponsor's protocol ID
- INY-P-20-001
- Status last verified
- Jun 2026
- First submitted
- 17 Aug 2020
- Last updated
- 29 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Abi-Jaoudeh N, Chen J, Dey C, Tahour D, Le T, Novelli P, Charalel R, Nadolski G, St Amour E. Multicenter Randomized Trial Evaluating the Safety and Effectiveness of the Instylla Hydrogel Embolic System for Vascular Occlusion of Hypervascular Tumors. J Vasc Interv Radiol. 2026 Oct;37(10):108946. doi: 10.1016/j.jvir.2026.108946. Epub 2026 Jul 6.
PubMed 42409306
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04523350
- Acronym / sponsor ID
- INY-P-20-001
- Conditions
- Hypervascular Tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Instylla, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Posted 29 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instylla HES | Experimental | Device: Instylla HES |
| Control | Active comparator | Other: TAE or cTACETAE or cTACE |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female subjects age ≥ 22 years old
- 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:
- 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.)
- Subjects with at least one target vessel ≤ 5mm and Instylla HES can be delivered to the target vessel(s).
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2 (PS 0-1 for metastatic disease)
Key exclusion criteria (21 listed)
- Embolization for lesions other than hypervascular tumors such as arteriovenous malformations.
- 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.
- Undergoing radioembolization or DEB-TACE for Index Procedure
- Undergoing a planned secondary procedure the same day as the Index Procedure
- Requires TAE/cTACE for liver tumors via extrahepatic collateral artery(ies)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instylla HESInstylla HES is a novel liquid embolic made of primarily water and polyethylene glycol (PEG) | Device | Instylla HES |
| TAE or cTACEAlso: ControlBland TAE or cTACE | Other | Control |
Primary outcome
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
Time frame: Immediately post-embolization procedure
Stasis of flow defined as absence of contrast flow within the targeted tumor feeding vessel
Primary Safety Endpoint: Freedom From Major Adverse Events Through 30 Days Post-index Procedure
Time frame: 30 days post-embolization procedure
Freedom from major adverse events through 30 days post-index procedure compared to a literature derived performance goal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42409306Abi-Jaoudeh N, Chen J, Dey C, Tahour D, Le T, Novelli P, Charalel R, Nadolski G, St Amour E. Multicenter Randomized Trial Evaluating the Safety and Effectiveness of the Instylla Hydrogel Embolic System for Vascular Occlusion of Hypervascular Tumors. J Vasc Interv Radiol. 2026 Oct;37(10):108946. doi: 10.1016/j.jvir.2026.108946. Epub 2026 Jul 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadine Abi-Jaoudeh, M.D. principal investigator
University of California, Irvine
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instylla HES and TAE or cTACE in people with Hypervascular Tumors, run by Instylla, Inc. at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Immediately post-embolization procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04523350, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.