Pulmonary NoduleNCT03893539
Clinical Utility for Ion Endoluminal System
A study testing Ion Endoluminal System™ in people with Pulmonary Nodule and Lung Cancer, run by Intuitive Surgical at 6 sites in United States.
Trial summary
The goal of this prospective, multi-center, single-arm, clinical study is to evaluate the clinical utility and performance of the FDA-cleared Ion™ Endoluminal System ("Ion") for bronchoscopically approaching and facilitating the tissue sampling of pulmonary nodules. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Nodule, Lung Cancer, Lung Diseases
- What is being tested?
- Ion Endoluminal System™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 6 sitesUnited States
- Study dates
- 29 Mar 2019to May 2024
- Phase
- Interventional
- 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
Who may be able to join
- Patients aged 18 years and older
- Patient is suitable for elective bronchoscopy
- Patients 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 ≤ 3cm in largest dimension
- Nodule is located in bronchial generation 4+ (i.e. beyond segmental bronchus*
- Patients are candidates for CT-guided needle biopsy and/or surgical resection
Show all 10Show fewer
- Patient able to understand and adhere to study requirements
- Patient able to understand and adhere to study requirements and able to provide informed consent
- Patient not legally incapacitated or in legal/court ordered institution
- Patients with 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 III or Class IV Pulmonary Hypertension or history of clinically significant mPAP
Show all 24Show fewer
- Lung abscess
- 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)
- Subjects with pure ground glass opacity target nodule
- Inability to adequately oxygenate subject during procedure per physicians discretion (i.e. unable to achieve S02 > 92% 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 ≥ 4
- Subjects taking antiplatelet (i.e. clopidogrel), anti-coagulant (i.e heparin or warfarin) or platelet aggression inhibitors (i.e. Abciximab 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 (i.e. >Stage 3 heart failure)
- Moderate-to-severe pulmonary fibrosis presenting procedural risk as assessed by physician
- Endobronchial lesion associated with lobar atelectasis
- Presence of bullae >1cm located within a cone based trajectory of biopsy instruments or in location presenting risk per physician assessment
- Known allergy, sensitivity or previous allergic reaction to ortho-phthalaldehyde (OPA)
- Subjects taking the following medications: Immunosuppressive treatment with systemic azathioprine, Cyclosporine, antibodies or cytostatics, other chemotherapeutic agents or medications acting on immunophilins
- Non-systemic treatment for lung cancer (i.e. SBRT, ablation) performed in the same lobe as the target nodule(s)
- Previous surgical intervention (i.e. wedge resection or lobectomy) within the same lobe as target nodule (s)
- Participation in any interventional clinical study or clinical study with experimental agents or agents of unknown risk in last 30 days prior to screening
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconness Medical Center
Boston, Massachusetts, 02215
Henry Ford Health System
Detroit, Michigan, 48202
MD Anderson Cancer Center
Houston, Texas, 77054
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: PRECIsE: A Prospective Evaluation of the Clinical Utility for the Ion Endoluminal System
The goal of this prospective, multi-center, single-arm, clinical study is to evaluate the clinical utility and performance of the FDA-cleared Ion™ Endoluminal System ("Ion") for bronchoscopically approaching and facilitating the tissue sampling of pulmonary nodules.
- Conditions
- Pulmonary Nodule, Lung Cancer, Lung Diseases
- Being tested
- Ion Endoluminal System™
- Medical subject headings
- Lung Neoplasms, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ion Endoluminal System™Device
The Ion™ Endoluminal System, Model IF1000, is a software-controlled, electro-mechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Bronchoscopy | Other | The Ion™ Endoluminal System assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use. Receives: Device: Ion Endoluminal System™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Navigation Success
Measured: Day 1 (Time of Procedure)
Biopsy Success
Measured: Day 1 (Time of Procedure)
Sensitivity for Malignancy of System-Obtained Sample
Measured: 14 months Post-Procedure
Secondary outcomes (1)
Complications
Measured: Intra-procedure, Immediately Post-Procedure, Day 10 Post-Procedure, Day 30 Post-Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start29 Mar 2019
- Primary completion26 May 2022
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary NoduleStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erik Folch, MD, Study chair, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893539
- Sponsor's protocol ID
- ISI-ION-001-2018
- Status last verified
- Mar 2024
- First submitted
- 26 Mar 2019
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Simoff MJ, Pritchett MA, Reisenauer JS, Ost DE, Majid A, Keyes C, Casal RF, Parikh MS, Diaz-Mendoza J, Fernandez-Bussy S, Folch EE. Shape-sensing robotic-assisted bronchoscopy for pulmonary nodules: initial multicenter experience using the Ion Endoluminal System. BMC Pulm Med. 2021 Oct 16;21(1):322. doi: 10.1186/s12890-021-01693-2.
PubMed 34656103Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.
PubMed 33590989
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRECIsE: A Prospective Evaluation of the Clinical Utility for the Ion Endoluminal System
- ClinicalTrials.gov ID
- NCT03893539
- Acronym / sponsor ID
- ISI-ION-001-2018
- Conditions
- Pulmonary Nodule, Lung Cancer, Lung Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 26 May 2022 (actual)
- Study completion
- May 2024 (estimated)
- First posted
- 28 Mar 2019 (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.
The goal of this prospective, multi-center, single-arm, clinical study is to evaluate the clinical utility and performance of the FDA-cleared Ion™ Endoluminal System ("Ion") for bronchoscopically approaching and facilitating the tissue sampling of pulmonary nodules.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic Bronchoscopy | Other | Device: Ion Endoluminal System™The Ion™ Endoluminal System assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged 18 years and older
- Patient is suitable for elective bronchoscopy
- Patients 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 ≤ 3cm in largest dimension
- Nodule is located in bronchial generation 4+ (i.e. beyond segmental bronchus*
Key exclusion criteria (24 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 System™The Ion™ Endoluminal System, Model IF1000, is a software-controlled, electro-mechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. | Device | Robotic Bronchoscopy |
Primary outcome
Navigation Success
Time frame: Day 1 (Time of Procedure)
Biopsy Success
Time frame: Day 1 (Time of Procedure)
Sensitivity for Malignancy of System-Obtained Sample
Time frame: 14 months Post-Procedure
1 secondary outcome
Complications
Time frame: Intra-procedure, Immediately Post-Procedure, Day 10 Post-Procedure, Day 30 Post-Procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Derived from this study: PubMed 34656103Simoff MJ, Pritchett MA, Reisenauer JS, Ost DE, Majid A, Keyes C, Casal RF, Parikh MS, Diaz-Mendoza J, Fernandez-Bussy S, Folch EE. Shape-sensing robotic-assisted bronchoscopy for pulmonary nodules: initial multicenter experience using the Ion Endoluminal System. BMC Pulm Med. 2021 Oct 16;21(1):322. doi: 10.1186/s12890-021-01693-2.
- Derived from this study: PubMed 33590989Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary Nodule
Active, not recruitingObservational study
Clinical Application of Artificial Intelligence Methods in Diagnostic Imaging of Pulmonary Nodules
Pulmonary Nodules, Lung Neoplasms
Recruiting
Longitudinal AI-Assisted Management of Indeterminate Pulmonary Nodules
Pulmonary Nodules, Lung Neoplasms
RecruitingObservational study
Study of Collection and Analysis of Clinical, Anamnestic, Functional, Biological Data Through the Support of Artificial Intelligence to Evaluate the Possibility of Defining a Digital Twin of the Lung (LUCE)
Thoracic Neoplasm, Pulmonary Nodules
Not yet recruitingObservational study
Diagnostic Performance of an AI-Based Multi-Omics Model for Early Lung Cancer
Pulmonary Nodules, Early Detection of Cancer
RecruitingObservational study
Liquid Biopsy Assay of EBUS-TBNA Supernatant Fluid for Diagnosing Lung Cancer
Non Small Cell Lung Cancer, Non Small Cell Lung Cancer (NSCLC)
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.
Erik Folch, MD study chair
Massachusetts General Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ion Endoluminal System™ in people with Pulmonary Nodule and Lung Cancer, run by Intuitive Surgical at 6 sites 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 24 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: status not confirmed, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Results are not available in the source record.
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?
Navigation Success (time frame: Day 1 (Time of Procedure)). The study lists 3 primary outcomes in all. 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 NCT03893539, which also lists 2 linked publications.
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 29 Mar 2024; AzTrials last refreshed its copy on 26 Oct 2026.