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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 : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
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
Estimated Study Start Date : March 29, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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.




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: 6 months Post-Procedure ]

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


Information from the National Library of Medicine

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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 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

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


Contacts
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Contact: Hiba Lejmi, MD 408-523-7202 Hiba.Lejmi@intusurg.com
Contact: Sundeep Master 408-523-1045 Sundeep.Master@intusurg.com

Locations
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United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Erik Folch, MD         
Beth Israel Deaconness Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Adnan Majid, MD         
Sub-Investigator: Mihir Parikh, MD         
United States, Michigan
Henry Ford Health System Not yet recruiting
Detroit, Michigan, United States, 48202
Contact: Michael Simoff, MD         
Sub-Investigator: Javier Diaz, MD         
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Janani Reisenauer, MD         
United States, North Carolina
FirstHealth Moore Regional Hospital Recruiting
Pinehurst, North Carolina, United States, 28374
Contact: Michael Pritchett, DO         
United States, Texas
MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77054
Contact: David Ost, MD         
Sponsors and Collaborators
Intuitive Surgical
Investigators
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Study Chair: Erik Folch, MD Massachusetts General Hospital

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Responsible Party: Intuitive Surgical
ClinicalTrials.gov Identifier: NCT03893539     History of Changes
Other Study ID Numbers: ISI-ION-001-2018
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

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