Phase 3
N=454
Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures
Lung Biopsy
Bottom Line
View on ClinicalTrials.gov: NCT02224924 ↗Enrolled (actual)
454
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: the Rate of Pneumothorax — 42; 60; 184; 168 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ABPI (Other); BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Rate of Pneumothorax |
42; 60; 184; 168 | — |
Summary
The purpose of this study is to compare two methods that are currently used at the end of a CT guided lung biopsy to close the hole on the surface of the lung in order to minimize the chance of air leaking out of the hole. The two techniques consist of either injecting a very small amount of your the blood called a blood patch into the biopsy hole or injecting a gel-based FDA approved artificial plug called BioSentry that will eventually get absorbed into the body.
Eligibility Criteria
Inclusion Criteria
- ≥18 years of age
- Referred for CT guided biopsy of lung lesion
- Target lesion of any size
- Target lesion located 1.5 cm or more away from visceral pleura based on the needle path
- Skin thickness ≤7 cm (from skin to pleura)
- Needle path without transgression of pleural fissure bleb, or bulla is possible
- Coaxial biopsy technique using Angiotech 19-Gauge introducer needle
- Needle length ≤15
Exclusion Criteria
- Passage through non-aerated lung or tissue
- More than 1 biopsy on the same side requiring more than 1 pleural puncture
- History of prior ipsilateral lung interventions including:
- Chest tube placement
- Surgery
- Pleurodesis
- Radiation treatment
Data sourced from ClinicalTrials.gov (NCT02224924). 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.