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

PHASE3CompletedINTERVENTIONAL
Enrollment

454

Participants

Timeline

Start Date

August 21, 2014

Primary Completion Date

January 11, 2023

Study Completion Date

January 11, 2023

Conditions
Lung Biopsy
Interventions
OTHER

ABPI

If the patient was assigned to the ABPI group, a blood patch will be administered using the clotted blood in the syringe obtained at the beginning of the procedure. The guiding needle will be retracted up to 1.5-2 cm from the pleural surface, and the blood will be injected steadily and gently as the needle is pulled back out of the pleura. Injection will stop when the operator feels the needle is in subcutaneous tissues.

DEVICE

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

If the patient is assigned to BioSentry group, using the manufacturer's deployment device the introducer needle is positioned so that the tip is at least 1.5 cm deep to the visceral pleura. The coaxial introducer needle hub will be prehydrated with a drop of saline, the BioSentry plug housing will be mated and locked to the hub and the plug will be deployed.

Trial Locations (2)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester, Harrison

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT02224924 - Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures | Biotech Hunter | Biotech Hunter