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

Completed

• Conditions: Lung Cancer; Pulmonary Nodule, Solitary
• Interventions: Device: Ion Endoluminal System

• Registration Number: NCT04735341
• Lead Sponsor: Intuitive Surgical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-09
• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-03
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with planned Ion Endoluminal Procedure with pulmonary nodule	Ion Endoluminal System	-

Primary Outcome Measures

Name	Time	Method
Ion Catheter Shape	Intra-operative	The collection of data relating to the Ion catheter shape

Trial Locations

Locations (1)

FirstHealth of the Carolinas Moore Regional Hospital; 🇺🇸 Pinehurst, North Carolina, United States