Clinical Utility for Ion Endoluminal System

NCT03893539 | Active Not Recruiting FDA Device

• 1 other identifier: ISI-ION-001-2018
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 6

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.

Conditions

Pulmonary Nodule; Lung Cancer; Lung Diseases

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Complications

  Intra-procedure, Immediately Post-Procedure, Day 10 Post-Procedure, Day 30 Post-Procedure

Study Arms (1)

Robotic Bronchoscopy

OTHER

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.

Device: Ion Endoluminal System™

Interventions

Ion Endoluminal System™ DEVICE

The Ion™ Endoluminal System, Model IF1000, is a software-controlled, electro-mechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures.

Robotic Bronchoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (6)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconness Medical Center

Boston, Massachusetts, 02215, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

FirstHealth Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77054, United States

Location

Related Publications (2)

• Simoff MJ, Pritchett MA, Reisenauer JS, Ost DE, Majid A, Keyes C, Casal RF, Parikh MS, Diaz-Mendoza J, Fernandez-Bussy S, Folch EE. Shape-sensing robotic-assisted bronchoscopy for pulmonary nodules: initial multicenter experience using the Ion Endoluminal System. BMC Pulm Med. 2021 Oct 16;21(1):322. doi: 10.1186/s12890-021-01693-2.

  PMID: 34656103 DERIVED

• Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.

  PMID: 33590989 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases

Study Officials

• Erik Folch, MD

  Massachusetts General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 28, 2019
• Study Start: March 29, 2019
• Primary Completion: May 26, 2022
• Study Completion: May 1, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

US (6)