Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed

Phase 3

Conditions

Lung Biopsy

Treatments

Device: BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug

Other: ABPI

Study type

Interventional

Funder types

Other

Identifiers

NCT02224924

14-141

Details and patient eligibility

About

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.

Full description

This study will determine the rate of all pneumothoraces and those pneumothoraces requiring treatment following percutaneous lung biopsy in patients who have received ABPI or BioSentry at the end of the biopsy procedure. The data collected will be used to determine if there is equal effectiveness in the reduction of pneumothorax rates from both interventions.

Enrollment

454 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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