WithdrawnNot Applicable

iNod™ Ultrasound-Guided Needle Biopsy System Study

Stopped: Sponsor decision

0Started 2025-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Proportion of patients where the needle is visualized by the iNOD system inside the lesion

Timeframe: Procedure

Adverse Events

Timeframe: Procedure

Trial details

NCT IDNCT05804435

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02

View on ClinicalTrials.gov More Solitary Pulmonary Nodule trials