Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
560 participants
INTERVENTIONAL
2018-05-04
2023-08-04
Brief Summary
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Computed Tomography (CT) Guided Lung Biopsy with BioSentry Plug, Evaluation of Safety and Efficacy.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Plug Arm
Participants randomized for plug arm will be treated with a plug after CT guided is conducted.
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.
Non Plug arm
No Intervention, i.a. CT guided biopsy without plug.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Male or female, aged ≥18 years or older
3. Percutaneous transthoracic needle lung biopsy indicated
18 Years
ALL
Yes
Sponsors
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University Hospital, Akershus
OTHER
Responsible Party
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Haseem Ashraf
Associate professor, PhD
Locations
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Haseem Ashraf
Lørenskog, Select A State, Norway
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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AHUS plug study 001
Identifier Type: -
Identifier Source: org_study_id
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