Lung CancerNCT04735341
Prospective Post-market Data Collection for Ion Endoluminal System to Understand CT to Body Divergence
An observational study of Lung Cancer and Pulmonary Nodule, Solitary, run by Intuitive Surgical at 1 site in United States.
Trial summary
The goal of this study is to collect post-market data for the Ion Endoluminal System to understand CT to body divergence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Pulmonary Nodule, Solitary
- What is being tested?
- Ion Endoluminal System
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2020to 30 Jun 2022
- 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
- Adult, Older adult
Study population: Subjects who will undergo an Ion Endoluminal Procedure with a pulmonary nodule, 18 years or older
Who may be able to join
- Age of 18 years or older
- Undergoing a lung biopsy procedure with Ion System
- Have peripheral pulmonary lesion (5th bronchial generation or higher)
- Willingness to participate as demonstrated by signing the informed consent
Who cannot join
- Unable to provide informed consent
- Presence of bilateral nodules intended to be biopsied during procedure
- The presence of medical conditions contraindicating general anesthesia or bronchoscopic biopsy
- Vulnerable population (e.g., prisoners, mentally disabled)
Trial locations and contacts
1 site in 1 country.
United States1 site
FirstHealth of the Carolinas Moore Regional Hospital
Pinehurst, North Carolina, 28374
About this study
The goal of this study is to collect post-market data for the Ion Endoluminal System to understand CT to body divergence.
- Conditions
- Lung Cancer, Pulmonary Nodule, Solitary
- Being tested
- Ion Endoluminal System
- Medical subject headings
- Lung Neoplasms, Solitary Pulmonary Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ion Endoluminal SystemDevice
Ion Endoluminal Procedure for pulmonary nodule
| Study group | Role | What they receive |
|---|---|---|
| Subjects with planned Ion Endoluminal Procedure with pulmonary nodule | Not described Receives: Device: Ion Endoluminal System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ion Catheter Shape
The collection of data relating to the Ion catheter shape
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start9 Dec 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735341
- Sponsor's protocol ID
- ISI-IonLR-001
- Status last verified
- Aug 2022
- First submitted
- 28 Jan 2021
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Post-market Data Collection for Ion Endoluminal System to Understand CT to Body Divergence
- ClinicalTrials.gov ID
- NCT04735341
- Acronym / sponsor ID
- ISI-IonLR-001
- Conditions
- Lung Cancer, Pulmonary Nodule, Solitary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 3 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.
The goal of this study is to collect post-market data for the Ion Endoluminal System to understand CT to body divergence.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with planned Ion Endoluminal Procedure with pulmonary nodule | – | Device: Ion Endoluminal System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects who will undergo an Ion Endoluminal Procedure with a pulmonary nodule, 18 years or older
Key inclusion criteria (4 listed)
- Age of 18 years or older
Key exclusion criteria (4 listed)
- Unable to provide informed consent
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 SystemIon Endoluminal Procedure for pulmonary nodule | Device | Subjects with planned Ion Endoluminal Procedure with pulmonary nodule |
Primary outcome
Ion Catheter Shape
Time frame: Intra-operative
The collection of data relating to the Ion catheter shape
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 9 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lung Cancer and Pulmonary Nodule, Solitary, run by Intuitive Surgical 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 4 inclusion and 4 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 9 Aug 2022. 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?
Ion Catheter Shape (time frame: Intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2022.