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Clinical Utility for Ion Endoluminal System

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ClinicalTrials.gov Identifier: NCT03893539
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Intuitive Surgical

Tracking Information
First Submitted Date  ICMJE March 26, 2019
First Posted Date  ICMJE March 28, 2019
Last Update Posted Date February 27, 2020
Actual Study Start Date  ICMJE March 29, 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2019)
  • Navigation Success [ Time Frame: Day 1 (Time of Procedure) ]
  • Biopsy Success [ Time Frame: Day 1 (Time of Procedure) ]
  • Sensitivity for Malignancy of System-Obtained Sample [ Time Frame: 6 months Post-Procedure ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2019)
  • Navigation Success [ Time Frame: Day 1 (Time of Procedure) ]
    The ability to reach the pre-planned target location characterized when displayed distance of parked catheter tip to nearest edge of the virtual target is ≤ 2cm
  • Biopsy Success [ Time Frame: Day 1 (Time of Procedure) ]
    The ability to obtain tissue sample from pre-planned target location, characterized by presence of feature other than bronchial epithelial cells.
  • Sensitivity for Malignancy [ Time Frame: 6 months Post-Procedure ]
    Outcome will be calculated using the number of subjects with true positive malignant diagnosis based on system obtained sample and/or physician assessment relative to the number of subjects with true positive malignant diagnosis and false negative samples
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2019)
Complications [ Time Frame: Immediately Post-Procedure, Day 10 Post-Procedure, Day 30 Post-Procedure ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2019)
Complications [ Time Frame: Immediately Post-Procedure, Day 10 Post-Procedure, Day 30 Post-Procedure ]
Assess the overall incidence of complications related to bronchoscopic biopsy procedure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Utility for Ion Endoluminal System
Official Title  ICMJE PRECIsE: A Prospective Evaluation of the Clinical Utility for the Ion Endoluminal System
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Pulmonary Nodule
  • Lung Cancer
  • Lung Diseases
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: Ion Endoluminal System™
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 26, 2019)
360
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 investigator prior to procedure
  • Acute myocardial infarction or unstable angina ≤ 6 weeks prior to study procedure
  • Partial trachea obstruction or obstruction of vena cava
  • Moderate to severe hypoxemia, acute respiratory failure or respiratory rate per physician assessment (i.e. > 30 breaths per minute)
  • Subjects with renal insufficiency that presents risk per physician's discretion or liver failure (i.e. CHILD-PUGH Class C)
  • Established history or clinical indication of pulmonary hypertension (i.e. history of mPAP > 35 mmHg)
  • Lung abscess
  • Debility and malnutrition
  • Known or suspected pregnancy
  • Recent head injury (<12 weeks pre-procedure) or subjects presenting with neurologic deficits or decreased cranial compliance
  • Unstable hemodynamic status (i.e. uncontrolled blood pressure or hypotension, 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 via nasal cannula)
  • 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 at least 7 days prior to procedure (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
  • Mediastinal lymphadenopathy on chest CT scan and/or PET CT
  • Endobronchial lesion associated with lobar atelectasis
  • Large or Giant bullae within the same lobe of the target pulmonary nodule
  • 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, or medications acting on immunophilins
  • Participation in any other clinical study in last 30 days prior to screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hiba Lejmi, MD 408-523-7202 Hiba.Lejmi@intusurg.com
Contact: Sundeep Master 408-523-1045 Sundeep.Master@intusurg.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03893539
Other Study ID Numbers  ICMJE ISI-ION-001-2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Intuitive Surgical
Study Sponsor  ICMJE Intuitive Surgical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Erik Folch, MD Massachusetts General Hospital
PRS Account Intuitive Surgical
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP