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Protocol Title:
Computed Tomography (CT) Guided Lung Biopsy with BioSentry Plug, Evaluation of Safety and Efficacy.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plug Arm | Experimental | Participants randomized for plug arm will be treated with a plug after CT guided is conducted. |
|
| Non Plug arm | No Intervention | No Intervention, i.a. CT guided biopsy without plug. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The BioSentry Tract Sealant System | Device | The BioSentry Tract Sealant System consists of a delivery system and a coaxial adapter with Bio-Sealâ„¢ plug. The hydrogel plug is deployed in the tract created by the lung biopsy needle and self-expands upon contact with moist tissue. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the rate of chest tube | Evaluate the rate of chest tube placement after percutaneous transthoracic needle lung biopsy | 2 years |
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Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haseem Ashraf, Associate professor, PhD | Contact | 0047 67964572 | ashr@ahus.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haseem Ashraf | Recruiting | Lørenskog | Select A State | 1476 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20656223 | Background | 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. | |
| 27826786 |
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| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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Block randomized design
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| 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. |
| 27870824 | Background | 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. |