Computed Tomography, Biopsy, Pneumothorax, Chest Tube, Plug
Conditions
Brief 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
Interventions
DEVICEThe 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.
Sponsors
University Hospital, Akershus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Block randomized design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Provide written informed consent prior to any study related procedure 2. Male or female, aged ≥18 years or older 3. Percutaneous transthoracic needle lung biopsy indicated
Exclusion criteria
There are no specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the rate of chest tube | 2 years | Evaluate the rate of chest tube placement after percutaneous transthoracic needle lung biopsy |
Countries
Norway
Contacts
Primary ContactHaseem Ashraf, Associate professor, PhD
Outcome results
None listed