Trial Outcomes & Findings for Pilot Study of Navigational Bronchoscopy and Transthoracic Needle Biopsy (NCT NCT02109458)

Results Overview

Feasibility assessed by number of participants with successful completion of biopsy (i.e. a biopsy was able to be obtained to collect a tissue sample)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

Immediately following procedure

Results posted on

2017-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	Assessing Peripheral Pulmonary Nodules To evaluate the feasibility and safety of a procedure path including convex Endobronchial Ultrasound (EBUS) lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA). Navigation guided bronchoscopy
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of Navigational Bronchoscopy and Transthoracic Needle Biopsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Assessing Peripheral Pulmonary Nodules n=24 Participants To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA). Navigation guided bronchoscopy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately following procedure

Feasibility assessed by number of participants with successful completion of biopsy (i.e. a biopsy was able to be obtained to collect a tissue sample)

Outcome measures

Outcome measures
Measure	Assessing Peripheral Pulmonary Nodules n=24 Participants To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA). Navigation guided bronchoscopy
Feasibility	24 participants

PRIMARY outcome

Timeframe: Immediately after procedure

Presence of pneumothorax assessed in participants with successful completion of biopsy.

Outcome measures

Outcome measures
Measure	Assessing Peripheral Pulmonary Nodules n=24 Participants To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA). Navigation guided bronchoscopy
Incidence of Pneumothorax	5 participants

SECONDARY outcome

Timeframe: Approximately 1 week upon receipt of pathology report

Positive diagnostic yield of bronchoscopic biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) alone was defined by participants having benign or malignant pathology.

Outcome measures

Outcome measures
Measure	Assessing Peripheral Pulmonary Nodules n=24 Participants To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA). Navigation guided bronchoscopy
Positive Diagnostic Yield of Bronchoscopic Biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) Alone	19 participants

SECONDARY outcome

Timeframe: Approximately 1 week upon receipt of pathology report

Positive diagnostic yield of bronchoscopic biopsy of ETTNA + EBUS + NB was defined by participants having benign or malignant pathology.

Outcome measures

Outcome measures
Measure	Assessing Peripheral Pulmonary Nodules n=24 Participants To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA). Navigation guided bronchoscopy
Positive Diagnostic Yield of Bronchoscopic Biopsy of ETTNA + EBUS + NB	21 participants

Adverse Events

Assessing Peripheral Pulmonary Nodules

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Assessing Peripheral Pulmonary Nodules n=24 participants at risk To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA). Navigation guided bronchoscopy
Respiratory, thoracic and mediastinal disorders Hemoptysis	0.00% 0/24

Additional Information

Dr. Lonny Yarmus

Johns Hopkins University School of Medicine

Phone: 4105025224

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place