Computed Tomography (CT) Guided Lung Biopsy With Plug
- Conditions
- Computed Tomography, Biopsy, Pneumothorax, Chest Tube, Plug
- Interventions
- Device: The BioSentry Tract Sealant System
- Registration Number
- NCT03526640
- Lead Sponsor
- University Hospital, Akershus
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 560
- Provide written informed consent prior to any study related procedure
- Male or female, aged ≥18 years or older
- Percutaneous transthoracic needle lung biopsy indicated
There are no specific exclusion criteria for the study. All participants are evaluated by a pulmonologist prior to admission and determined eligible for the procedure.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Plug Arm The BioSentry Tract Sealant System Participants randomized for plug arm will be treated with a plug after CT guided is conducted.
- Primary Outcome Measures
Name Time Method Evaluate the rate of chest tube 2 years Evaluate the rate of chest tube placement after percutaneous transthoracic needle lung biopsy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Haseem Ashraf
🇳🇴Lørenskog, Select A State, Norway