Clinical trial NCT04740047: Cios Mobile 3D Spin for Robotic Bronchoscopy
Official title: Cios Mobile 3D Spin for Robotic Bronchoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Nodule, Solitary
Pulmonary Cancer
Lung Cancer
Lung Cancer, Nonsmall Cell
Lung Adenocarcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Intuitive Surgical
name: Siemens Corporation, Corporate Technology
First posted: 2021-02-05
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from pulmonary, medical oncology or thoracic surgery departments at the Mayo Clinic Rochester.

Brief summary: Evaluate the clinical utility and early performance of the Cios 3D Mobile Spin in conjunction with the Ion Endoluminal System, to visualize and facilitate the sampling of pulmonary nodules between 1-3 cm via the airway.


Eligibility criteria: Inclusion Criteria:

* Subject age 18 years and older
* Subject is suitable for elective bronchoscopy
* Subject 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 ≤3.5 cm in largest dimension
* Nodule is located in bronchial generation 4+ (i.e. beyond segmental bronchus)
* Subject is a candidate for CT-guided needle biopsy
* Subject is able to understand and adhere to study requirements
* Subject is able to understand and adhere to study requirements and able to provide informed consent
* Subject is not legally incapacitated or in legal/court ordered institution
* Subject has 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 IV Pulmonary Hypertension or history of clinically significant mPAP
* 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)
* Inability to adequately oxygenate subject during procedure per physicians discretion (i.e. unable to achieve S02 \> 88% 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 ≥ 5
* 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
* Moderate-to-severe pulmonary fibrosis presenting procedural risk as assessed by physician
* Endobronchial lesion associated with lobar atelectasis
* Known allergy, sensitivity or previous allergic reaction to ortho-phthalaldehyde (OPA)
* Non-systemic treatment for lung cancer (i.e. SBRT) performed in the same lobe as the target nodule(s)
* Previous surgical intervention performed in the same lobe as the target nodule (s)

Primary outcomes:
measure: Tool in Lesion
timeFrame: At the time of the procedure
Secondary outcomes:
measure: Procedure-related complications
timeFrame: 6 months
measure: Duration-related outcomes
timeFrame: At the time of the procedure
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Janani Reisenauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reisenauer J, Duke JD, Kern R, Fernandez-Bussy S, Edell E. Combining Shape-Sensing Robotic Bronchoscopy With Mobile Three-Dimensional Imaging to Verify Tool-in-Lesion and Overcome Divergence: A Pilot Study. Mayo Clin Proc Innov Qual Outcomes. 2022 Apr 23;6(3):177-185. doi: 10.1016/j.mayocpiqo.2022.02.004. eCollection 2022 Jun.