NCT03526640

Computed Tomography (CT) Guided Lung Biopsy With Plug

Computed Tomography (CT) Guided Lung Biopsy With Plug - Evaluation of Safety and Efficacy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: University Hospital, Akershus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Protocol Title: Computed Tomography (CT) Guided Lung Biopsy with BioSentry Plug, Evaluation of Safety and Efficacy.

Detailed description

Protocol Summary: Prospective, randomized, controlled, unblinded, post-market, single-center clinical study Objectives: Patients treated with the BioSentry system will be compared to patients not treated with the BioSentry System (Control Group). Primary Objective: Evaluate the rate of chest tube placement after percutaneous transthoracic needle lung biopsy Secondary Objectives: Evaluate the rate of intra-procedural pneumothorax Evaluate the rate of post-procedural pneumothorax Evaluate cost associated with complications Evaluate the number of hospital admissions

Conditions

• Computed Tomography, Biopsy, Pneumothorax, Chest Tube, Plug

Interventions

Type	Name	Description
DEVICE	The BioSentry Tract Sealant System	The BioSentry Tract Sealant System consists of a delivery system and a coaxial adapter with Bio-Seal™ plug. The hydrogel plug is deployed in the tract created by the lung biopsy needle and self-expands upon contact with moist tissue.

Timeline

• Start date: 2018-05-04
• Primary completion: 2020-08-04
• Completion: 2023-08-04
• First posted: 2018-05-16
• Last updated: 2018-05-16

Locations

1 site across 1 country: Norway