Cios Mobile 3D Spin for Robotic Bronchoscopy

June 25, 2024 updated by: Janani S. Reisenauer, Mayo Clinic
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Robotic bronchoscopy with c-arm imaging.
Other Names:
  • Cios 3D mobile spin system

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tool in Lesion
Time Frame: At the time of the procedure
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedure-related complications
Time Frame: 6 months
Overall incidence of procedure-related complications recorded as adverse events.
6 months
Duration-related outcomes
Time Frame: At the time of the procedure
Reporting of times related to procedure times including procedure time, navigation time, time to 3D confirmation, time to tissue acquisitions, anesthesia time, and fluoroscopy time and dose.
At the time of the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Intuitive Surgical
Siemens Corporation, Corporate Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Janani Reisenauer, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-004757

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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