NCT04735341

Brief Summary

The goal of this study is to collect post-market data for the Ion Endoluminal System to understand CT to body divergence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 9, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

1.6 years

First QC Date

January 28, 2021

Last Update Submit

August 8, 2022

Conditions

Lung CancerPulmonary Nodule, Solitary

Outcome Measures

Primary Outcomes (1)

  • Ion Catheter Shape

    The collection of data relating to the Ion catheter shape

    Intra-operative

Study Arms (1)

Subjects with planned Ion Endoluminal Procedure with pulmonary nodule

Device: Ion Endoluminal System

Interventions

Ion Endoluminal SystemDEVICE

Ion Endoluminal Procedure for pulmonary nodule

Subjects with planned Ion Endoluminal Procedure with pulmonary nodule

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FirstHealth of the Carolinas Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsSolitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2021

First Posted

February 3, 2021

Study Start

December 9, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

August 9, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)