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Pressure-enabled Delivery in Radioembolization (TriNav Study)

NCT05128032 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-19

No results posted yet for this study

Summary

The purpose of the study is to determine if the type of catheter used in the mapping procedure prior to radioembolization improves the delivery of radioactivity to tumor(s) in participants with liver cancer.

The name of the devices involved in this study are:

* Pressure Enabled Drug Delivery (PEDD)/TriNav Infusion System
* Standard 2.4F microcatheter, not otherwise specified

Conditions

Interventions

DEVICE

Standard microcatheter

Small device used for mapping as part of radioembolization procedure

DEVICE

PEDD device

Pressure enabled small device used for mapping as part of radioembolization procedure

Sponsors & Collaborators

  • TriSalus Life Sciences, Inc.

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Patrick D Sutphin, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2026-06-01
Completion
2026-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05128032 on ClinicalTrials.gov