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

Intuitive Surgical

Status: Completed

Conditions: Pulmonary Nodule, Solitary; Lung Cancer

Treatments: Device: Ion Endoluminal System

Study type: Observational

Funder types: Industry

Identifiers

NCT04735341

ISI-IonLR-001

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

30 participants in 1 patient group

Subjects with planned Ion Endoluminal Procedure with pulmonary nodule

Treatment:

Device: Ion Endoluminal System