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Clinical Utility for Ion Endoluminal System

NCT03893539 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2024-03-29

No results posted yet for this study

Summary

The goal of this prospective, multi-center, single-arm, clinical study is to evaluate the clinical utility and performance of the FDA-cleared Ion™ Endoluminal System ("Ion") for bronchoscopically approaching and facilitating the tissue sampling of pulmonary nodules.

Conditions

Interventions

DEVICE

Ion Endoluminal System™

The Ion™ Endoluminal System, Model IF1000, is a software-controlled, electro-mechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures.

Sponsors & Collaborators

  • Intuitive Surgical

    lead INDUSTRY

Principal Investigators

  • Erik Folch, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-29
Primary Completion
2022-05-26
Completion
2024-05-31
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 NCT03893539 on ClinicalTrials.gov