Clinical trial NCT02832284: iNod System Human Feasibility Assessment
Official title: Feasibility Study of a Bronchoscopic Ultrasound-Guided Tissue Acquisition System With Real-time Visualization for Collection of Cytology Specimens of Peripheral Pulmonary Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solitary Pulmonary Nodule
Biopsy, Fine-Needle
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2016-07-14
Enrollment: 23
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 demonstrate feasibility to access, visualize, and obtain specimens adequate for cytology of lung lesions in subjects with suspected lung cancer when using the iNod System.

Detailed description: This protocol is a traditional feasibility study for the sampling of a peripheral pulmonary lesion in the setting of a suspicion of lung cancer. Standard of practice radial endobronchial ultrasound (R-EBUS) transbronchial needle aspiration (TBNA) is visualizing a peripheral lesion on R-EBUS, locking the placement of the access sheath, removing the ultrasound catheter from the access sheath and then blindly advancing a sampling device to acquire cellular matter for cytologic evaluation. The iNod system performs the same procedure with one fewer device exchange. It provides real-time visualization of the biopsy needle and target peripheral pulmonary lesions during tissue acquisition. The ultrasound probe is not retracted in advance of the sampling maneuver and the sampling is completed under direct visualization. Compared to current standard of care methods for transbronchial sampling of pulmonary lesions, this approach is not expected to add additional risk. Tissue sampling under real-time visualization may improve the efficiency of tissue sampling.

Eligibility criteria: Inclusion Criteria:

1. Subject is age 18 years or older.
2. Subject is willing and able to comply with study procedures and provide written informed consent to participate in study.
3. Subject with a predominantly solid lung lesion, 1 cm to 7 cm in diameter, which has been identified on chest CT (obtained within 6 weeks) 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 80% of the lesion.
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, a subsolid target lesion, and/or a ground glass opacity identified on Chest CT.
2. Subjects with lesions that include endobronchial involvement, per Chest CT.
3. Subjects who lack fitness to undergo flexible bronchoscopy and standard of care Radial EBUS-guided cytological assessment evaluations, as determined by the investigator.
4. Subjects with known coagulopathy.
5. Subjects who are pregnant or nursing mothers.
6. Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.

Primary outcomes:
measure: Acquisition of Adequate Specimens of Targeted Lung Lesions
timeFrame: Intraprocedural
Secondary outcomes:
measure: Device/Procedure-Related Safety Events
timeFrame: Procedure through Post-procedure call; 6-8 days post-procedure.
measure: Visualization
timeFrame: Intraprocedural
measure: Access
timeFrame: Intraprocedural
measure: Acquisition
timeFrame: Intraprocedural
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University Medical School
state: Maryland
city: Saint Louis
country: United States
facility: Washington University of St. Louis
state: Missouri
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical Director, Boston Scientific
name: Thomas Bowman, MD
role: STUDY_DIRECTOR
References: