Pulmonary Nodule, SolitaryNCT04740047
Cios Mobile 3D Spin for Robotic Bronchoscopy
An observational study of Pulmonary Nodule, Solitary and Pulmonary Cancer, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Nodule, Solitary, Pulmonary Cancer, Lung Cancer
- What is being tested?
- Ion Endoluminal System
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 22 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from pulmonary, medical oncology or thoracic surgery departments at the Mayo Clinic Rochester.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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
- Being tested
- Ion Endoluminal System
- Medical subject headings
- Solitary Pulmonary Nodule, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ion Endoluminal SystemDiagnostic test
Also called Cios 3D mobile spin system
Robotic bronchoscopy with c-arm imaging.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Ion Endoluminal System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of the procedure
Secondary outcomes (2)
Procedure-related complications
Overall incidence of procedure-related complications recorded as adverse events.
Measured: 6 months
Duration-related outcomes
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.
Measured: At the time of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 Feb 2021
- Primary completion4 Nov 2022
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Nodule, SolitaryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Intuitive Surgical, Siemens Corporation, Corporate Technology
- Responsible party
- Principal investigator, Janani S. Reisenauer, Mayo Clinic
- Investigators
- Janani Reisenauer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740047
- Sponsor's protocol ID
- 20-004757
- Status last verified
- Jun 2024
- First submitted
- 1 Feb 2021
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35509435
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cios Mobile 3D Spin for Robotic Bronchoscopy
- ClinicalTrials.gov ID
- NCT04740047
- Acronym / sponsor ID
- 20-004757
- Conditions
- Pulmonary Nodule, Solitary, Pulmonary Cancer, Lung Cancer, Lung Cancer, Nonsmall Cell, Lung Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Intuitive Surgical, Siemens Corporation, Corporate Technology
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Nodule | – | Diagnostic Test: Ion Endoluminal SystemPulmonary 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from pulmonary, medical oncology or thoracic surgery departments at the Mayo Clinic Rochester.
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ion Endoluminal SystemAlso: Cios 3D mobile spin systemRobotic bronchoscopy with c-arm imaging. | Diagnostic test | Pulmonary Nodule |
Primary outcome
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.
2 secondary outcomes
Procedure-related complications
Time frame: 6 months
Duration-related outcomes
Time frame: At the time of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Derived from this study: PubMed 35509435Reisenauer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janani Reisenauer, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Nodule, Solitary and Pulmonary Cancer, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tool in Lesion (time frame: At the time of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04740047, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.