Prospective Post-market Data Collection for Ion Endoluminal System to Understand CT to Body Divergence

August 8, 2022 updated by: Intuitive Surgical
The goal of this study is to collect post-market data for the Ion Endoluminal System to understand CT to body divergence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Pinehurst, North Carolina, United States, 28374
        • FirstHealth of the Carolinas Moore Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who will undergo an Ion Endoluminal Procedure with a pulmonary nodule, 18 years or older

Description

Inclusion Criteria:

  • Age of 18 years or older

    • Undergoing a lung biopsy procedure with Ion System
    • Have peripheral pulmonary lesion (5th bronchial generation or higher)
    • Willingness to participate as demonstrated by signing the informed consent

Exclusion Criteria:

  • Unable to provide informed consent

    • Presence of bilateral nodules intended to be biopsied during procedure
    • The presence of medical conditions contraindicating general anesthesia or bronchoscopic biopsy
    • Vulnerable population (e.g., prisoners, mentally disabled)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects with planned Ion Endoluminal Procedure with pulmonary nodule
Device: Ion Endoluminal System
Ion Endoluminal Procedure for pulmonary nodule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ion Catheter Shape
Time Frame: Intra-operative
The collection of data relating to the Ion catheter shape
Intra-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intuitive Surgical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 9, 2020

Primary Completion (ACTUAL)

June 30, 2022

Study Completion (ACTUAL)

June 30, 2022

Study Registration Dates

First Submitted

January 28, 2021

First Submitted That Met QC Criteria

February 2, 2021

First Posted (ACTUAL)

February 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISI-IonLR-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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