Cios Mobile 3D Spin for Robotic Bronchoscopy

NCT ID: NCT04740047

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2023-05-22

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Ion Endoluminal System

Intervention Type: DIAGNOSTIC_TEST

Robotic bronchoscopy with c-arm imaging.

Interventions

Ion Endoluminal System

Robotic bronchoscopy with c-arm imaging.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Cios 3D mobile spin system

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intuitive Surgical

INDUSTRY

Sponsor Role: collaborator

Siemens Corporation, Corporate Technology

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Janani S. Reisenauer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janani Reisenauer, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35509435 (View on PubMed)

Other Identifiers

20-004757

Identifier Type: -

Identifier Source: org_study_id