A Retrospective Multicenter Review to Evaluate the Performance of the Ion Endoluminal System in Sampling Pulmonary Lesions

NCT05160571 | Completed FDA Device

• 1 other identifier: ISI-ION-R01
• Study Type: observational
• Target: 279
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system.

Conditions

Lung Cancer; Pulmonary Nodule

Outcome Measures

Primary Outcomes (4)

• Diagnostic yield

  Diagnostic yield of the sample obtained through the bronchoscopy procedure, with diagnostic yield defined as (true positives + true negatives)/(total number of lesions biopsied)

  Intra-operative through the one year follow up period

• Sensitivity for malignancy

  Sensitivity for malignancy of the sample obtained

  Intra-operative through the one year follow up period

• Pneumothorax

  Incidence of all pneumothoraces related to the Ion procedure

  Intra-operative

• Bleeding

  Incidence of bleeding in which an intervention was required, related to the Ion procedure. Interventions include: administration of cold saline, vasoactive substances, thrombin, or similar in response to active bleeding; use of bronchial/balloon blocker; use of bronchial artery embolization or resuscitation or ICU admission.

  Intra-operative

Secondary Outcomes (2)

• Adverse events

  Intra-operative through 30 days

• Conversion to alternate approach or termination of procedure

  Intra-operative

Study Arms (1)

Subjects with Ion Endoluminal sampling of pulmonary nodule

Subjects in which a pulmonary lesion biopsy was attempted or performed with the Ion Endoluminal System

Device: Ion Endoluminal System

Interventions

Ion Endoluminal System DEVICE

Ion Endoluminal Procedure for pulmonary nodule

Subjects with Ion Endoluminal sampling of pulmonary nodule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Subject was 18 years or older at the time of the procedure
• Biopsy procedure attempted/performed using the Ion Endoluminal System

You may not qualify if:

• Biopsy procedure was not attempted with the Ion Endoluminal System
• Biopsy procedure attempted with the Ion Endoluminal System occurred less than 12 months prior to IRB approval

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (1)

Winchester Medical Center

Winchester, Virginia, 22601, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Glen Bouder, MD

  Winchester Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: December 16, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)