Instylla HES for Tumors

UAB Hospital, Birmingham, AL
TumorsInstylla HES - Device
Eligibility
18+
All Sexes

Study Summary

This trial is comparing Instylla HES to standard of care transarterial embolization/conventional transarterial chemoembolization to see if it is effective and safe.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Immediately post-embolization procedure

30 days post-embolization procedure
Primary Safety Endpoint: Freedom from major adverse events through 30 days post-index procedure
Immediately post-embolization procedure
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

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Control
1 of 2
Instylla HES
1 of 2

Active Control

Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: Instylla HES · No Placebo Group · N/A

Instylla HES
Device
Experimental Group · 1 Intervention: Instylla HES · Intervention Types: Device
Control
Other
ActiveComparator Group · 1 Intervention: TAE or cTACE · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: immediately post-embolization procedure

Who is running the clinical trial?

Instylla, Inc.Lead Sponsor
1 Previous Clinical Trials
118 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

How many participants have been accepted into this research program?

"To carry out this scientific endeavour, 150 patients who meet the inclusion requirements need to be identified. Instylla, Inc., is managing the trial from a number of centres such as Boston Medical Center in Massachusetts and Northwell Health, Inc. located in Manhasset, New York." - Anonymous Online Contributor

Unverified Answer

Are there any centers in the US that are currently undertaking this research?

"Boston Medical Center in Boston, Massachusetts, Northwell Health Inc. in Manhasset, New York and University of Colorado Anschutz Medical Center in Aurora, Colorado are just 3 out the 17 clinical trial sites delivering this treatment." - Anonymous Online Contributor

Unverified Answer

Are there any slots still available for this experiment?

"According to information found on clinicaltrials.gov, this research project is presently looking for test subjects. The trial was initially uploaded on April 1st 2021 and the last update occurred November 4th 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.