Clinical trial NCT03893539: Clinical Utility for Ion Endoluminal System
Official title: PRECIsE: A Prospective Evaluation of the Clinical Utility for the Ion Endoluminal System
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Nodule
Lung Cancer
Lung Diseases
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2019-03-28
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Navigation Success
timeFrame: Day 1 (Time of Procedure)
measure: Biopsy Success
timeFrame: Day 1 (Time of Procedure)
measure: Sensitivity for Malignancy of System-Obtained Sample
timeFrame: 14 months Post-Procedure
Secondary outcomes:
measure: Complications
timeFrame: Intra-procedure, Immediately Post-Procedure, Day 10 Post-Procedure, Day 30 Post-Procedure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconness Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Pinehurst
country: United States
facility: FirstHealth Moore Regional Hospital
state: North Carolina
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Massachusetts General Hospital
name: Erik Folch, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.