Clinical trial NCT05804435: iNod™ Ultrasound-Guided Needle Biopsy System 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Solitary Pulmonary Nodule
Multiple Pulmonary Nodules
Biopsy, Fine-Needle
Keywords: Post-Market
Pulmonary Lesions
iNod
R-EBUS
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2023-04-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older.
2. Subject willing and able to comply with study procedures and provide written informed consent to participate in study.
3. 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.

   a. "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.
4. Subject for whom the decision to pursue biopsy has been made by the treating physician and agreed upon by the subject.

Exclusion Criteria:

1. 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.
2. 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.
3. Subjects with known coagulopathy.
4. Subjects who are pregnant or nursing mothers.
5. Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.
6. Use of intraprocedural Cone Beam CT, Fixed CT or Augmented fluoroscopy

Primary outcomes:
measure: Proportion of patients where the needle is visualized by the iNOD system inside the lesion
timeFrame: Procedure
measure: Adverse Events
timeFrame: Procedure
Secondary outcomes:
Other outcomes:
measure: Biopsy Yield
timeFrame: Procedure
measure: Diagnostic Accuracy
timeFrame: 12 months post procedure
measure: Device Rotation
timeFrame: Procedure
measure: Crossover Rate
timeFrame: Procedure
Locations:
Study officials:
affiliation: Barnes-Jewish Hospital
name: Alexander Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: