Solitary Pulmonary NoduleNCT05804435
iNod™ Ultrasound-Guided Needle Biopsy System Study
A study testing iNod™ System in people with Solitary Pulmonary Nodule and Multiple Pulmonary Nodules, run by Boston Scientific Corporation.
Trial summary
The purpose of this study is to collect information on the iNod™ System's safety and ability to see the iNod™ biopsy needle in real-time in endobronchial lesions, peripheral lung nodules, or lung masses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules, Biopsy, Fine-Needle
- What is being tested?
- iNod™ System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Feb 2027
- 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
- Age 18 years or older.
- Subject willing and able to comply with study procedures and provide written informed consent to participate in study.
- Subject with a predominantly solid, peripheral lung lesion, 1 cm to 5 cm in diameter measured along its longest cross sectional diameter on axial CT imaging (obtained within 4 weeks per standard of practice) with the intention to undergo a clinically indicated bronchoscopic evaluation under routine clinical care. If the lesion is partially solid (i.e. there is a ground glass component) then the solid portion must make up at least 80% of the lesion.
- "Peripheral" lesion in this study will be pragmatically defined as any lesion in the lung parenchyma that the clinician feels cannot be accessed successfully using the convex probe endobronchial ultrasound bronchoscope.
- Subject for whom the decision to pursue biopsy has been made by the treating physician and agreed upon by the subject.
Who cannot join
- Subjects with pure ground glass opacity or a subsolid target lesion, and/or a ground glass opacity for which less than 80% of the lesion is solid identified by Chest CT.
- Subjects who have medical contraindication to undergo conventional flexible or robotic bronchoscopy and standard of care Radial EBUS-guided cytological assessment evaluations, as determined by the investigator.
- Subjects with known coagulopathy.
- Subjects who are pregnant or nursing mothers.
- Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.
- Use of intraprocedural Cone Beam CT, Fixed CT or Augmented fluoroscopy
About this study
Official title: Prospective Multi-center Study Using a Bronchoscopic Ultrasound-Guided Needle Biopsy System With Real-time Visualization in Endobronchial Lesions, Peripheral Lung Nodules, or Lung Masses
The purpose of this study is to collect information on the iNod™ System's safety and ability to see the iNod™ biopsy needle in real-time in endobronchial lesions, peripheral lung nodules, or lung masses.
Read the detailed description
This post-market study intends to further demonstrate the ability and safety of the iNod™ Ultrasound Guidance System and iNod™ Ultrasound Biopsy needle to perform transbronchial needle biopsy of endobronchial lesions, peripheral lung nodules, or lung masses under real-time ultrasound visualization. This is a prospective, multi-center case series of standard of care peripheral lung nodule biopsy procedures with up to 115 subjects at up to 10 centers.
- Being tested
- iNod™ System
- Keywords
- Post-Market, Pulmonary Lesions, iNod, R-EBUS
- Medical subject headings
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iNod™ SystemDevice
Also called iNod™ Ultrasound Imaging System, iNod™ SUD
The iNod™ Ultrasound Imaging System enables visualization of endobronchial lesions, peripheral lung nodules, or lung masses (referred to as lesions) using R-EBUS and performance of lung biopsy under direct R-EBUS visualization.
| Study group | Role | What they receive |
|---|---|---|
| iNod™ System | Experimental | Subjects with a qualifying lung lesion will have a standard of care Transbronchial Needle Aspiration using the the iNod™ System Receives: Device: iNod™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients where the needle is visualized by the iNOD system inside the lesion
Successful "Tool in lesion", defined as visualization of the tracheobronchial biopsy needle (TBNA) inside the targeted lesion within the ultrasound field of view.
Measured: Procedure
Adverse Events
Proportion of subjects with Adverse Events related to the iNod device and/or study procedure, as well as Adverse Events related to any subsequent crossover procedures.
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study startJan 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2027 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solitary Pulmonary NoduleStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander Chen, MD, Principal investigator, Barnes-Jewish Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804435
- Sponsor's protocol ID
- E7186
- Status last verified
- Mar 2024
- First submitted
- 27 Mar 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-center Study Using a Bronchoscopic Ultrasound-Guided Needle Biopsy System With Real-time Visualization in Endobronchial Lesions, Peripheral Lung Nodules, or Lung Masses
- ClinicalTrials.gov ID
- NCT05804435
- Acronym / sponsor ID
- E7186
- Keywords
- Post-Market, Pulmonary Lesions, iNod, R-EBUS
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 7 Apr 2023 (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 purpose of this study is to collect information on the iNod™ System's safety and ability to see the iNod™ biopsy needle in real-time in endobronchial lesions, peripheral lung nodules, or lung masses.
Detailed description
This post-market study intends to further demonstrate the ability and safety of the iNod™ Ultrasound Guidance System and iNod™ Ultrasound Biopsy needle to perform transbronchial needle biopsy of endobronchial lesions, peripheral lung nodules, or lung masses under real-time ultrasound visualization. This is a prospective, multi-center case series of standard of care peripheral lung nodule biopsy procedures with up to 115 subjects at up to 10 centers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iNod™ System | Experimental | Device: iNod™ SystemSubjects with a qualifying lung lesion will have a standard of care Transbronchial Needle Aspiration using the the iNod™ System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Subject willing and able to comply with study procedures and provide written informed consent to participate in study.
- Subject with a predominantly solid, peripheral lung lesion, 1 cm to 5 cm in diameter measured along its longest cross sectional diameter on axial CT imaging (obtained within 4 weeks per standard of practice) with the intention to undergo a clinically indicated bronchoscopic evaluation under routine clinical care. If the lesion is partially solid (i.e. there is a ground glass component) then the solid portion must make up at least 80% of the lesion.
- Subject for whom the decision to pursue biopsy has been made by the treating physician and agreed upon by the subject.
Key exclusion criteria (6 listed)
- Subjects with pure ground glass opacity or a subsolid target lesion, and/or a ground glass opacity for which less than 80% of the lesion is solid identified by Chest CT.
- Subjects who have medical contraindication to undergo conventional flexible or robotic bronchoscopy and standard of care Radial EBUS-guided cytological assessment evaluations, as determined by the investigator.
- Subjects with known coagulopathy.
- Subjects who are pregnant or nursing mothers.
- Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.
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 |
|---|---|---|
| iNod™ SystemAlso: iNod™ Ultrasound Imaging System, iNod™ SUDThe iNod™ Ultrasound Imaging System enables visualization of endobronchial lesions, peripheral lung nodules, or lung masses (referred to as lesions) using R-EBUS and performance of lung biopsy under direct R-EBUS visualization. | Device | iNod™ System |
Primary outcome
Proportion of patients where the needle is visualized by the iNOD system inside the lesion
Time frame: Procedure
Successful "Tool in lesion", defined as visualization of the tracheobronchial biopsy needle (TBNA) inside the targeted lesion within the ultrasound field of view.
Adverse Events
Time frame: Procedure
Proportion of subjects with Adverse Events related to the iNod device and/or study procedure, as well as Adverse Events related to any subsequent crossover procedures.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- 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.
Alexander Chen, MD principal investigator
Barnes-Jewish Hospital
Questions about this trial
What is this clinical trial studying?
A study testing iNod™ System in people with Solitary Pulmonary Nodule and Multiple Pulmonary Nodules, run by Boston Scientific Corporation.
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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Proportion of patients where the needle is visualized by the iNOD system inside the lesion (time frame: Procedure). The study lists 2 primary outcomes in all. 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 8 Mar 2024.