N/A
N=24
Pilot Study of Navigational Bronchoscopy and Transthoracic Needle Biopsy
Peripheral Pulmonary Nodules
Bottom Line
View on ClinicalTrials.gov: NCT02109458 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Feasibility — 24 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Navigation guided bronchoscopy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility |
24 | — |
| PRIMARY Incidence of Pneumothorax |
5 | — |
| SECONDARY Positive Diagnostic Yield of Bronchoscopic Biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) Alone |
19 | — |
| SECONDARY Positive Diagnostic Yield of Bronchoscopic Biopsy of ETTNA + EBUS + NB |
21 | — |
Summary
The goal of this study is to evaluate the feasibility and safety of navigation guided virtual transthoracic needle biopsy combined with navigational bronchoscopy for the diagnosis of peripheral pulmonary nodules (PPN).
Eligibility Criteria
Inclusion criteria
- Target patient population: Patients with a peripheral pulmonary nodule as identified on CT chest ≤3cm from the pleura will be recruited. A PPN will be defined as a lesion >10mm and <3cm in diameter surrounded by lung parenchyma on CT chest. The decision for biopsy of the PPN will be made by the treating physician and agreed upon by the patient.
- Participants must be at least 18 years old or older
- No bleeding disorders
- Provide informed consent.
Exclusion criteria
- less than 18 years
- lack of fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure
- inability to give informed consent
Data sourced from ClinicalTrials.gov (NCT02109458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.