Cios Mobile 3D Spin for Robotic Bronchoscopy

NCT04740047 | Completed DMC FDA Device

• 1 other identifier: 20-004757
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Nodule, Solitary; Pulmonary Cancer; Lung Cancer; Lung Cancer, Nonsmall Cell; Lung Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Tool in Lesion

  Ability to visualize on 3D imaging the pre-planned target location characterized when displayed distance of catheter tip to nearest edge of the virtual target is ≤ 2cm and is oriented towards the lesion in 3 axes.

  At the time of the procedure

Secondary Outcomes (2)

• Procedure-related complications

  6 months

• Duration-related outcomes

  At the time of the procedure

Study Arms (1)

Pulmonary Nodule

Pulmonary nodule is suitable for elective bronchoscopy with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information or with suspected metastatic disease.

Diagnostic Test: Ion Endoluminal System

Interventions

Ion Endoluminal System DIAGNOSTIC_TEST

Robotic bronchoscopy with c-arm imaging.

Also known as: Cios 3D mobile spin system

Pulmonary Nodule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from pulmonary, medical oncology or thoracic surgery departments at the Mayo Clinic Rochester.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Intuitive Surgical: collaborator
• Siemens Corporation, Corporate Technology: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 35509435 DERIVED

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Janani Reisenauer, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 5, 2021
• Study Start: February 1, 2021
• Primary Completion: November 4, 2022
• Study Completion: May 22, 2023
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)