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Instylla HES Hypervascular Tumor Pivotal Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04523350
Recruitment Status : Recruiting
First Posted : August 21, 2020
Last Update Posted : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
Instylla, Inc.

Study Description
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Brief Summary:
To determine whether Instylla HES has the ability to effectively embolize targeted arterial segments of hypervascular tumors as well as standard of care (SOC) transarterial embolization/conventional transarterial chemoembolization, while resulting in an acceptable risk of device and procedure-related serious adverse events.

Condition or disease Intervention/treatment Phase
Hypervascular Tumors Device: Instylla HES Other: TAE or cTACE Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 4, 2021
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : July 31, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Instylla HES Device: Instylla HES
Instylla HES is a novel liquid embolic made of primarily water and polyethylene glycol (PEG)
Active Comparator: Control
TAE or cTACE
 Other: TAE or cTACE
Bland TAE or cTACE
Other Name: Control


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Primary Safety Endpoint: Freedom from major adverse events through 30 days post-index procedure [ Time Frame: 30 days post-embolization procedure ]

Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects age ≥ 22 years old
  • Subjects with confirmed finding of hypervascular tumor on CT and/or MRI for whom TAE/TACE is medically indicated
  • ECOG PS of 0-2 (PS 0-1 for metastatic disease)
  • Expected life expectancy ≥ 6 months after Index embolization

Exclusion Criteria:

  • Embolization for lesions other than hypervascular tumors such as arteriovenous malformations
  • Undergoing radioembolization or DEB-TACE for Index Procedure
  • Prior radioembolization of the target tumor lesion/vascular bed
  • For subjects with HCC or undergoing embolization to the liver: Child-Pugh Class C or presence of complete portal vein thrombosis
  • Tumor lesions >8cm in diameter (in one direction) or >50% tumor volume burden of the target organ
  • Any contraindication to arteriography or embolization protocol
  • Pregnant or breast-feeding or females planning on becoming pregnant within the next 3 months
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04523350


Contacts
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Contact: Chelsea Reinhold 781-209-6516 chelsear@instylla.com
Contact: Brooke Mastrorio 781-790-4863 brookem@instylla.com

Locations
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Australia, Victoria
Alfred Health Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Gerard Goh         
Contact: Helen Kavnoudias         
Sponsors and Collaborators
Instylla, Inc.
More Information
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Responsible Party: Instylla, Inc.
ClinicalTrials.gov Identifier: NCT04523350    
Other Study ID Numbers: INY-P-20-001
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes