Clinical Utility for Ion Endoluminal System

Not Applicable

Active, not recruiting

• Conditions: Lung Cancer; Lung Diseases; Pulmonary Nodule
• Interventions: Device: Ion Endoluminal System™

• Registration Number: NCT03893539
• Lead Sponsor: Intuitive Surgical

Brief Summary

The goal of this prospective, multi-center, single-arm, clinical study is to evaluate the clinical utility and performance of the FDA-cleared Ion™ Endoluminal System ("Ion") for bronchoscopically approaching and facilitating the tissue sampling of pulmonary nodules.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-28
• Study Start: 2019-03-29
• Primary Completion: 2022-05-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-29
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 365

Inclusion Criteria

• Patients aged 18 years and older
• Patient is suitable for elective bronchoscopy
• Patients 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 ≤ 3cm in largest dimension
• Nodule is located in bronchial generation 4+ (i.e. beyond segmental bronchus*
• Patients are candidates for CT-guided needle biopsy and/or surgical resection
• Patient able to understand and adhere to study requirements
• Patient able to understand and adhere to study requirements and able to provide informed consent
• Patient not legally incapacitated or in legal/court ordered institution
• Patients with 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 III or Class IV Pulmonary Hypertension or history of clinically significant mPAP
• Lung abscess
• 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)
• Subjects with pure ground glass opacity target nodule
• Inability to adequately oxygenate subject during procedure per physicians discretion (i.e. unable to achieve S02 > 92% 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 ≥ 4
• Subjects taking antiplatelet (i.e. clopidogrel), anti-coagulant (i.e heparin or warfarin) or platelet aggression inhibitors (i.e. Abciximab 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 (i.e. >Stage 3 heart failure)
• Moderate-to-severe pulmonary fibrosis presenting procedural risk as assessed by physician
• Endobronchial lesion associated with lobar atelectasis
• Presence of bullae >1cm located within a cone based trajectory of biopsy instruments or in location presenting risk per physician assessment
• Known allergy, sensitivity or previous allergic reaction to ortho-phthalaldehyde (OPA)
• Subjects taking the following medications: Immunosuppressive treatment with systemic azathioprine, Cyclosporine, antibodies or cytostatics, other chemotherapeutic agents or medications acting on immunophilins
• Non-systemic treatment for lung cancer (i.e. SBRT, ablation) performed in the same lobe as the target nodule(s)
• Previous surgical intervention (i.e. wedge resection or lobectomy) within the same lobe as target nodule (s)
• Participation in any interventional clinical study or clinical study with experimental agents or agents of unknown risk in last 30 days prior to screening

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robotic Bronchoscopy	Ion Endoluminal System™	The Ion™ Endoluminal System assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use.

Primary Outcome Measures

Name	Time	Method
Navigation Success	Day 1 (Time of Procedure)
Biopsy Success	Day 1 (Time of Procedure)
Sensitivity for Malignancy of System-Obtained Sample	14 months Post-Procedure

Secondary Outcome Measures

Name	Time	Method
Complications	Intra-procedure, Immediately Post-Procedure, Day 10 Post-Procedure, Day 30 Post-Procedure

Trial Locations

Locations (6)

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

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Beth Israel Deaconness Medical Center; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States