Computed Tomography (CT) Guided Lung Biopsy With Plug
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03526640|
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Computed Tomography (CT) Guided Lung Biopsy with BioSentry Plug, Evaluation of Safety and Efficacy.
|Condition or disease||Intervention/treatment||Phase|
|Computed Tomography, Biopsy, Pneumothorax, Chest Tube, Plug||Device: The BioSentry Tract Sealant System||Not Applicable|
Prospective, randomized, controlled, unblinded, post-market, single-center clinical study
Patients treated with the BioSentry system will be compared to patients not treated with the BioSentry System (Control Group).
Evaluate the rate of chest tube placement after percutaneous transthoracic needle lung biopsy
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||560 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Block randomized design|
|Masking:||None (Open Label)|
|Official Title:||Computed Tomography (CT) Guided Lung Biopsy With Plug - Evaluation of Safety and Efficacy|
|Actual Study Start Date :||May 4, 2018|
|Estimated Primary Completion Date :||August 4, 2020|
|Estimated Study Completion Date :||August 4, 2023|
Experimental: Plug Arm
Participants randomized for plug arm will be treated with a plug after CT guided is conducted.
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.
No Intervention: Non Plug arm
No Intervention, i.a. CT guided biopsy without plug.
- Evaluate the rate of chest tube [ Time Frame: 2 years ]Evaluate the rate of chest tube placement after percutaneous transthoracic needle lung biopsy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526640
|Contact: Haseem Ashraf, Associate professor, PhD||0047 email@example.com|
|Lørenskog, Select A State, Norway, 1476|
|Contact: Haseem Ashraf, Associate professor, PhD 0047 6796572 firstname.lastname@example.org|