Computed Tomography (CT) Guided Lung Biopsy With Plug

Computed Tomography, Biopsy, Pneumothorax, Chest Tube, Plug Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03526640
• Other study ID #: AHUS plug study 001
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2018
• Est. completion date: August 4, 2023

Study information

• Verified date: May 2018
• Source: University Hospital, Akershus
• Contact: Haseem Ashraf, Associate professor, PhD
• Phone: 0047 67964572
• Email: ashr[@]ahus.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Protocol Title:

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: August 4, 2023
• Est. primary completion date: August 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 exclusion criteria for the study. All participants are evaluated by a pulmonologist prior to admission and determined eligible for the procedure.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Norway	Haseem Ashraf	Lørenskog	Select A State

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Ahrar JU, Gupta S, Ensor JE, Mahvash A, Sabir SH, Steele JR, McRae SE, Avritscher R, Huang SY, Odisio BC, Murthy R, Ahrar K, Wallace MJ, Tam AL. Efficacy of a Self-expanding Tract Sealant Device in the Reduction of Pneumothorax and Chest Tube Placement Rates After Percutaneous Lung Biopsy: A Matched Controlled Study Using Propensity Score Analysis. Cardiovasc Intervent Radiol. 2017 Feb;40(2):270-276. doi: 10.1007/s00270-016-1489-9. Epub 2016 Nov 8. — View Citation

Grage RA, Naveed MA, Keogh S, Wang D. Efficacy of a Dehydrated Hydrogel Plug to Reduce Complications Associated With Computed Tomography-guided Percutaneous Transthoracic Needle Biopsy. J Thorac Imaging. 2017 Jan;32(1):57-62. doi: 10.1097/RTI.0000000000000247. — View Citation

Zaetta JM, Licht MO, Fisher JS, Avelar RL; Bio-Seal Study Group. A lung biopsy tract plug for reduction of postbiopsy pneumothorax and other complications: results of a prospective, multicenter, randomized, controlled clinical study. J Vasc Interv Radiol. 2010 Aug;21(8):1235-43.e1-3. doi: 10.1016/j.jvir.2010.04.021. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the rate of chest tube	Evaluate the rate of chest tube placement after percutaneous transthoracic needle lung biopsy	2 years