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A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy

Intuitive Surgical logo

Intuitive Surgical

Status

Active, not recruiting

Conditions

Lung Cancer

Treatments

Device: Ion Endoluminal System and Cios Spin

Study type

Observational

Funder types

Industry

Identifiers

NCT05562895
ISI-ION-002

Details and patient eligibility

About

The overall objective of this study is to evaluate procedure characteristics of pulmonary nodule biopsies using the integrated version of Cios Spin and the Ion Endoluminal System.

Full description

This study is a post-market, prospective, multicenter, single-arm study of subjects undergoing a pulmonary nodule biopsy using the Ion Endoluminal System in conjunction with the Cios Spin. The aim of the study is to evaluate the integrated version of the two systems. The primary outcomes of the study are focused on evaluating the procedure characteristics of the pulmonary nodule biopsy procedure, including diagnostic yield, sensitivity for malignancy, and rate of tool in nodule.

Enrollment

155 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject is 18 years or older at the time of the procedure.
  • Pulmonary nodule biopsy attempted/performed using the Ion Endoluminal System and Cios Spin 3D imaging.
  • Pulmonary nodule ≤2 cm in largest diameter.
  • Subject able to understand and adhere to study requirements and provide informed consent.

Exclusion criteria

  • Planned lymph node staging performed before nodule biopsy.
  • Nodule is a pure ground glass opacity.
  • Plan to biopsy multiple nodules.

Trial design

155 participants in 1 patient group

Subjects with biopsy of pulmonary nodule using Ion Endoluminal System and Cios Spin
Description:
Subjects in which a pulmonary nodule biopsy was attempted or performed with the integrated Ion Endoluminal System and Cios Spin
Treatment:
Device: Ion Endoluminal System and Cios Spin

Trial contacts and locations

6

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Central trial contact

Alison Gorski; Sundeep Master

Data sourced from clinicaltrials.gov

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