Cios Mobile 3D Spin for Robotic Bronchoscopy

NCT04740047•Mayo Clinic

Summary

Evaluate the clinical utility and early performance of the Cios 3D Mobile Spin in conjunction with the Ion Endoluminal System, to visualize and facilitate the sampling of pulmonary nodules between 1-3 cm via the airway.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject age 18 years and older
•Subject is suitable for elective bronchoscopy
•Subject with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information or with suspected metastatic disease
•Solid or semi-solid pulmonary nodules of ≥ 1cm and ≤3.5 cm in largest dimension
•Nodule is located in bronchial generation 4+ (i.e. beyond segmental bronchus)
•Subject is a candidate for CT-guided needle biopsy
•Subject is able to understand and adhere to study requirements
•Subject is able to understand and adhere to study requirements and able to provide informed consent
•Subject is not legally incapacitated or in legal/court ordered institution
•Subject has no dependency on the investigator or sponsor

Exclusion Criteria

•Lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by physician prior to procedure
•Acute myocardial infarction or unstable angina ≤ 6 weeks prior to study procedure
•Clinically relevant partial trachea obstruction or obstruction of vena cava per physician assessment
•Acute respiratory failure, clinically significant hypoxemia, or high respiratory rate (i.e. \> 30 breaths per minute) per physician assessment
•Renal insufficiency that presents risk per physician's discretion or liver failure (i.e. CHILD-PUGH Class C)
•World Health Organization functional Class IV Pulmonary Hypertension or history of clinically significant mPAP
•Known or suspected pregnancy
•Recent head injury (\<12 weeks pre-procedure) or subjects presenting with clinically significant neurologic deficits
•Unstable hemodynamic status (i.e. Dysrhythmia requiring intervention, altered mental status/consciousness)
•Inability to adequately oxygenate subject during procedure per physicians discretion (i.e. unable to achieve S02 \> 88% or requiring \>4L of oxygen prior to procedure)
+9 more criteria

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

February 1, 2021

Primary Completion Date

November 4, 2022

Completion Date

May 22, 2023

Last Updated

June 27, 2024

Enrollment

ACTUAL participants

Conditions

Pulmonary Nodule, SolitaryPulmonary CancerLung CancerLung Cancer, Nonsmall CellLung Adenocarcinoma

Interventions

Ion Endoluminal System

DIAGNOSTIC_TEST

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

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RECRUITINGPHASE3

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NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Cios Mobile 3D Spin for Robotic Bronchoscopy

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial