Cios Mobile 3D Spin for Robotic Bronchoscopy

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Lung Adenocarcinoma; Lung Cancer, Nonsmall Cell; Pulmonary Cancer; Pulmonary Nodule, Solitary
• Intervention / Treatment: Diagnostic test: Ion Endoluminal System

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from pulmonary, medical oncology or thoracic surgery departments at the Mayo Clinic Rochester.

Description

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)
• Subject with uncorrectable coagulopathy, bleeding or platelet disorders, history of major bleeding with bronchoscopy
• Subjects contraindicated for intubation or general anesthesia, or subjects with ASA ≥ 5
• Subjects taking antiplatelet (i.e. clopidogrel), anti-coagulant (i.e. heparin or warfarin) or /platelet aggression inhibitors (i.e. Abciximac or Eptifibatide) medications that cannot be stopped per standard practice, i.e. 5-7 days pre-procedure or heparin that cannot be held according to standard practice (6-12 hours). Aspirin not included.
• Any severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy
• Moderate-to-severe pulmonary fibrosis presenting procedural risk as assessed by physician
• Endobronchial lesion associated with lobar atelectasis
• Known allergy, sensitivity or previous allergic reaction to ortho-phthalaldehyde (OPA)
• Non-systemic treatment for lung cancer (i.e. SBRT) performed in the same lobe as the target nodule(s)
• Previous surgical intervention performed in the same lobe as the target nodule (s)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pulmonary Nodule; Pulmonary nodule is suitable for elective bronchoscopy with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information or with suspected metastatic disease.	Diagnostic test: Ion Endoluminal System; Robotic bronchoscopy with c-arm imaging.; Other Names: Cios 3D mobile spin system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tool in Lesion	Ability to visualize on 3D imaging the pre-planned target location characterized when displayed distance of catheter tip to nearest edge of the virtual target is ≤ 2cm and is oriented towards the lesion in 3 axes.	At the time of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure-related complications	Overall incidence of procedure-related complications recorded as adverse events.	6 months
Duration-related outcomes	Reporting of times related to procedure times including procedure time, navigation time, time to 3D confirmation, time to tissue acquisitions, anesthesia time, and fluoroscopy time and dose.	At the time of the procedure

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Intuitive Surgical; Siemens Corporation, Corporate Technology
• Investigators: Principal Investigator: Janani Reisenauer, MD, Mayo Clinic

Publications and helpful links

General Publications

• Reisenauer J, Duke JD, Kern R, Fernandez-Bussy S, Edell E. Combining Shape-Sensing Robotic Bronchoscopy With Mobile Three-Dimensional Imaging to Verify Tool-in-Lesion and Overcome Divergence: A Pilot Study. Mayo Clin Proc Innov Qual Outcomes. 2022 Apr 23;6(3):177-185. doi: 10.1016/j.mayocpiqo.2022.02.004. eCollection 2022 Jun.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): November 4, 2022
• Study Completion (Actual): May 22, 2023

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Multiple Pulmonary Nodules; Adenocarcinoma of Lung; Solitary Pulmonary Nodule
• Other Study ID Numbers: 20-004757

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No