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Clinical Utility for Ion Endoluminal System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03893539
Recruitment Status : Active, not recruiting
First Posted : March 28, 2019
Last Update Posted : September 16, 2022
Sponsor:
Information provided by (Responsible Party):
Intuitive Surgical

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pulmonary Nodule Lung Cancer Lung Diseases Device: Ion Endoluminal System™ Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: PRECIsE: A Prospective Evaluation of the Clinical Utility for the Ion Endoluminal System
Actual Study Start Date : March 29, 2019
Estimated Primary Completion Date : December 26, 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Robotic Bronchoscopy
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™
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.


Outcome Measures
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Primary Outcome Measures :
  1. Navigation Success [ Time Frame: Day 1 (Time of Procedure) ]
  2. Biopsy Success [ Time Frame: Day 1 (Time of Procedure) ]
  3. Sensitivity for Malignancy of System-Obtained Sample [ Time Frame: 14 months Post-Procedure ]

Secondary Outcome Measures :
  1. Complications [ Time Frame: Intra-procedure, Immediately Post-Procedure, Day 10 Post-Procedure, Day 30 Post-Procedure ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03893539


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, North Carolina
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77054
Sponsors and Collaborators
Intuitive Surgical
Investigators
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Study Chair: Erik Folch, MD Massachusetts General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Intuitive Surgical
ClinicalTrials.gov Identifier: NCT03893539    
Other Study ID Numbers: ISI-ION-001-2018
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: September 16, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Multiple Pulmonary Nodules
Lung Diseases
Respiratory Tract Diseases
Lung Neoplasms
 Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms