A Study to Evaluate the Clinical Utility for the Ion™ Endoluminal System

Overview

About this study

The purpose of this study is to evaluate the clinical utility and early performance of the FDA cleared Ion™ Endoluminal System (“Ion”) for brochoscopically approaching and facilitating the sampling of peripheral pulmonary nodules, between 1-3cm in size, of unknown etiology.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

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.
  • (**) For stage 0 only, subjects must have a Solid or semi-solid pulmonary nodules of ≥ 1cm and ≤ 3.5cm in largest dimension.

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., Abciximac 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) performed in the same lobe as the target nodule(s).
  • Previous surgical intervention (i.e., wedge resection or lobectomy) on ipsilateral side of 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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Janani Reisenauer, M.D.

Open for enrollment

Contact information:

Pulmonary Clinical Research Unit

(800) 753-1606

PCRUE18@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20461093

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