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Assess Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System

TriNaV

Dania Daye, MD

Maria Koch, MD

The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid treatment in patients undergoing UFE.

Uterine fibroids are the most common tumor type in women of reproductive age and may be associated with abnormal menstrual bleeding, pain, sub-fertility, and diminished quality of life. For women interested in uterine preservation who want to derive adequate relief from medical management, uterine fibroid embolization (UFE) is a treatment option. The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid treatment in patients undergoing UFE.

Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization

Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System (PEDD-UFE)

The Visual Analog Scale (VAS) Pain score will be used to assess pre- and post-procedural pain. The scale is from 1 to 10 with 1 indicating no pain and 10 indicating extreme pain.

Ultrasound doppler imaging will be used to assess changes in ovarian perfusion post-intervention compared to baseline ultrasound imaging

TriSalus Life Sciences, Inc.

Massachusetts General Hospital

Assistant Professor of Radiology

Digestive System Diseases

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Chlorotrianisene

Liver Extracts

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Patients will receive a single administration of intra-arterial chemotherapy (Doxorubicin) during the TACE procedure via TriNav.

* Patients will undergo structural follow-up for a timeframe of one year post treatment
* Post-procedural, contrast-enhanced Magnetic Resonance Imaging (MRI) will be performed one month after trial entry, and at regular intervals thereafter for a total of one year to assess tumor response

Patients will receive a single administration of intra-arterial chemotherapy (Doxorubicin) during the TACE procedure via Traditional Delivery.

* Patients will undergo structural follow-up for a timeframe of one year post treatment
* Post-procedural, contrast-enhanced Magnetic Resonance Imaging (MRI) will be performed one month after trial entry, and at regular intervals thereafter for a total of one year to assess tumor response

TriNav is a modified microcatheter with an expandable cone at its tip to prevent retrograde reflux of flow and change flow dynamics downstream.

TriNav

Low profile tubing microcatheter for easier access to more peripheral/distal vascular branches for precise targeted delivery of medications.

Traditional Delivery

Medication used in cancer chemotherapy, including intraarterial delivery for liver malignancies.

Dmitry Rabkin, MD, PhD

This research study is studying the TriNav ("TriSalus") for increasing delivery of chemotherapeutic agents delivered trans-arterially to intermediate stage Hepatocellular Carcinoma ("HCC") (Barcelona Clinic Liver Cancer (BCLC) class B; locally advanced, liver restricted disease patients.

The names of the study interventions involved in this study are:

-Trans-arterial chemoembolization ("TACE") with or without the utilization of Surefire

This research study is a randomized Pilot study, which is the first time investigators are examining use of the TriNav device to improve tumor perfusion. Specifically, this study compares TACE both with or without the use of the TriNav device

Investigators are doing this research to determine if a TriNav Infusion System can improve tumor response to liver-directed intra-arterial chemotherapy compared to a traditional microcatheter.

TriNav is a Food and Drug Administration-approved valve-like device that blocks backflow within the artery but also generates increased pressure in a tumor feeder vessel during infusion. During this study, participants will receive the same medication in the same dose and the same way it would be delivered to the liver as a standard of care procedure, only either through a regular microcatheter (which is the standard of care procedure) or a TriNav Infusion System (which is a modified microcatheter).

Effect of Surefire Infusion Device on Tumor Response to Regional Intra-arterial Therapy for Primary Liver Malignancies

Ktrans represents a calculated metric that represents a measure of capillary permeability obtained during dynamic contrast enhanced MRI; it represents an absolute value of tracer concentration within the tissue of interest. It is calculated by measuring the accumulation of contrast agent on post-contrast MR images within a given tissue over time and comparing it to a baseline contrast-filled structure such as a blood vessel. The measurement represents accumulation of contrast for a given tissue, as determined by the investigator.

Normality of the distribution will be tested using Shapiro-Wilk test. To compare Ktrans, the investigators will apply t-test or Wilcoxon rank sum test as appropriate.

Calculation of this value allows for more detailed analysis of contrast-enhancement of the tissue of interest. It represents an absolute value of tracer concentration within the tissue of interest, similar to Ktrans.

Calculation of this value allows for more detailed analysis of contrast-enhancement of the tissue of interest. It represents a derived value (kep = ktrans/ve) and is dependent upon ktrans and ve.

Calculation of this value allows for more detailed analysis of contrast-enhancement of the tissue of interest. It represents an absolute value of tracer concentration within the plasma and allows for more accurate measurement of tissue permeability.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization	NCT06106633	Uterine Bleedin... Uterine Fibroid	TriNaV	18 Years - 60 Years	Massachusetts General Hospital
Effect of Surefire Infusion Device on Tumor Response to Regional Intra-arterial Therapy for Primary Liver Malignancies	NCT02853500	Liver Cancer	TriNav Traditional Del... Doxorubicin	18 Years - 75 Years	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for trinav

Every month we try and update this database with for trinav cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for trinav

Every month we try and update this database with for trinav cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for trinav cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.