Trial Outcomes & Findings for iNod System Human Feasibility Assessment (NCT NCT02832284)

NCT ID: NCT02832284

Last Updated: 2021-02-11

Results Overview

The primary endpoint for the iNod Feasibility Study was clinical success, defined as the iNod System's ability to acquire adequate specimens of cellular matter suitable for the cytologic evaluation of targeted lung lesions, under real-time visualization.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: Intraprocedural
• Results posted on: 2021-02-11

Participant Flow

Participant milestones

Measure	iNod System Multi-center, Prospective, Single-arm Feasibility Study with Salvage. iNod System: The iNod System is intended for use for diagnostic ultrasound imaging and ultrasound-guided fine needle aspiration (FNA) of extramural and submucosal lesions of the tracheobronchial tree.
Overall Study STARTED	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

iNod System Human Feasibility Assessment

Baseline characteristics by cohort

Measure	iNod System n=86 Attepmts at target lesions Multi-center, Prospective, Single-arm Feasibility Study with Salvage. iNod System: The iNod System is intended for use for diagnostic ultrasound imaging and ultrasound-guided fine needle aspiration (FNA) of extramural and submucosal lesions of the tracheobronchial tree. Per, protocol, each of the 23 enrolled subjects underwent evaluations with the iNod System. For study subjects for whom an adequate specimen, defined as a specimen that has been confirmed as suitable for cytologic evaluation, is not obtained from the iNod System diagnostic procedure but for whom continuation with endobronchial maneuvers are not contraindicated, additional standard of care (SOC) R-EBUS-guided diagnostic sampling maneuvers should be conducted.
Age, Continuous	68.0 years n=23 Participants
Sex: Female, Male Female	12 Participants n=23 Participants
Sex: Female, Male Male	11 Participants n=23 Participants
Region of Enrollment United States	23 participants n=23 Participants

PRIMARY outcome

Timeframe: Intraprocedural

The primary endpoint for the iNod Feasibility Study was clinical success, defined as the iNod System's ability to acquire adequate specimens of cellular matter suitable for the cytologic evaluation of targeted lung lesions, under real-time visualization.

Outcome measures

Measure	iNod System n=23 Participants Multi-center, Prospective, Single-arm Feasibility Study with Salvage. iNod System: The iNod System is intended for use for diagnostic ultrasound imaging and ultrasound-guided fine needle aspiration (FNA) of extramural and submucosal lesions of the tracheobronchial tree.
Acquisition of Adequate Specimens of Targeted Lung Lesions	9 Participants

SECONDARY outcome

Timeframe: Procedure through Post-procedure call; 6-8 days post-procedure.

Occurrence and severity of Adverse Events related to the iNod System biopsy procedures, as well as Adverse Events related to any subsequent Radial EBUS-guided salvage procedures.

Outcome measures

Measure	iNod System n=23 Participants Multi-center, Prospective, Single-arm Feasibility Study with Salvage. iNod System: The iNod System is intended for use for diagnostic ultrasound imaging and ultrasound-guided fine needle aspiration (FNA) of extramural and submucosal lesions of the tracheobronchial tree.
Device/Procedure-Related Safety Events	6 Participants

SECONDARY outcome

Timeframe: Intraprocedural

Population: Lesions visualized per attempt to visualize lesion

Lesions visualized during iNod Maneuvers

Outcome measures

Measure	iNod System n=86 Lesions visualization attempts Multi-center, Prospective, Single-arm Feasibility Study with Salvage. iNod System: The iNod System is intended for use for diagnostic ultrasound imaging and ultrasound-guided fine needle aspiration (FNA) of extramural and submucosal lesions of the tracheobronchial tree.
Visualization	72 Lesions visualization attempts

SECONDARY outcome

Timeframe: Intraprocedural

Population: Lesions accessed per attempt to access lesion

Lesions accessed where iNod Biopsy Needles were deployed in the target lesion during study maneuvers

Outcome measures

Measure	iNod System n=86 Lesions access attempts Multi-center, Prospective, Single-arm Feasibility Study with Salvage. iNod System: The iNod System is intended for use for diagnostic ultrasound imaging and ultrasound-guided fine needle aspiration (FNA) of extramural and submucosal lesions of the tracheobronchial tree.
Access	72 Lesions access attempts

SECONDARY outcome

Timeframe: Intraprocedural

Population: Specimens of cellular matter for cytology per attempt, to acquire cellular matter.

iNod maneuvers that acquired specimens of cellular matter for cytology

Outcome measures

Measure	iNod System n=78 Specimens of cellular matter for cytolog Multi-center, Prospective, Single-arm Feasibility Study with Salvage. iNod System: The iNod System is intended for use for diagnostic ultrasound imaging and ultrasound-guided fine needle aspiration (FNA) of extramural and submucosal lesions of the tracheobronchial tree.
Acquisition	69 Specimens of cellular matter for cytolog

Adverse Events

iNod System

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	iNod System n=23 participants at risk Multi-center, Prospective, Single-arm Feasibility Study with Salvage. iNod System: The iNod System is intended for use for diagnostic ultrasound imaging and ultrasound-guided fine needle aspiration (FNA) of extramural and submucosal lesions of the tracheobronchial tree.
Infections and infestations Pseudomonas Pneumonia	4.3% 1/23 • Number of events 1 • Adverse event data was collected from the Baseline/Consenting Visit, through study exit; typically 7 days. Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, whether or not related to the investigational medical device. NOTE 1: This includes events related to the investigational medical device or comparator. NOTE 2: This definition includes events related to the procedures involved (any procedure in the clinical investigation plan).
Respiratory, thoracic and mediastinal disorders Haemoptysis	4.3% 1/23 • Number of events 1 • Adverse event data was collected from the Baseline/Consenting Visit, through study exit; typically 7 days. Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, whether or not related to the investigational medical device. NOTE 1: This includes events related to the investigational medical device or comparator. NOTE 2: This definition includes events related to the procedures involved (any procedure in the clinical investigation plan).

Other adverse events

Measure	iNod System n=23 participants at risk Multi-center, Prospective, Single-arm Feasibility Study with Salvage. iNod System: The iNod System is intended for use for diagnostic ultrasound imaging and ultrasound-guided fine needle aspiration (FNA) of extramural and submucosal lesions of the tracheobronchial tree.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	4.3% 1/23 • Number of events 1 • Adverse event data was collected from the Baseline/Consenting Visit, through study exit; typically 7 days. Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, whether or not related to the investigational medical device. NOTE 1: This includes events related to the investigational medical device or comparator. NOTE 2: This definition includes events related to the procedures involved (any procedure in the clinical investigation plan).
Respiratory, thoracic and mediastinal disorders Cough	4.3% 1/23 • Number of events 1 • Adverse event data was collected from the Baseline/Consenting Visit, through study exit; typically 7 days. Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, whether or not related to the investigational medical device. NOTE 1: This includes events related to the investigational medical device or comparator. NOTE 2: This definition includes events related to the procedures involved (any procedure in the clinical investigation plan).
Respiratory, thoracic and mediastinal disorders Haemoptysis	17.4% 4/23 • Number of events 4 • Adverse event data was collected from the Baseline/Consenting Visit, through study exit; typically 7 days. Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, whether or not related to the investigational medical device. NOTE 1: This includes events related to the investigational medical device or comparator. NOTE 2: This definition includes events related to the procedures involved (any procedure in the clinical investigation plan).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.7% 2/23 • Number of events 2 • Adverse event data was collected from the Baseline/Consenting Visit, through study exit; typically 7 days. Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, whether or not related to the investigational medical device. NOTE 1: This includes events related to the investigational medical device or comparator. NOTE 2: This definition includes events related to the procedures involved (any procedure in the clinical investigation plan).

Additional Information

G Mark Grubb, RN, CCRA

Boston Scientific Corporation

Phone: 412 749 1423

Email: grubbm@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place