Cios Mobile 3D Spin for Robotic Bronchoscopy

Completed

• Conditions: Lung Adenocarcinoma; Pulmonary Nodule, Solitary; Pulmonary Cancer; Lung Cancer, Nonsmall Cell; Lung Cancer
• Interventions: Diagnostic Test: Ion Endoluminal System

• Registration Number: NCT04740047
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-05
• Primary Completion: 2022-11-04
• Study Completion: 2023-05-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pulmonary Nodule	Ion Endoluminal System	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.

Primary Outcome Measures

Name	Time	Method
Tool in Lesion	At the time of the procedure	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.

Secondary Outcome Measures

Name	Time	Method
Procedure-related complications	6 months	Overall incidence of procedure-related complications recorded as adverse events.
Duration-related outcomes	At the time of the procedure	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States