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Computed Tomography (CT) Guided Lung Biopsy With Plug

Primary Purpose

Computed Tomography, Biopsy, Pneumothorax, Chest Tube, Plug

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
The BioSentry Tract Sealant System
Sponsored by
University Hospital, Akershus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Computed Tomography, Biopsy, Pneumothorax, Chest Tube, Plug

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Haseem AshrafRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Plug Arm

Non Plug arm

Arm Description

Participants randomized for plug arm will be treated with a plug after CT guided is conducted.

No Intervention, i.a. CT guided biopsy without plug.

Outcomes

Primary Outcome Measures

Evaluate the rate of chest tube
Evaluate the rate of chest tube placement after percutaneous transthoracic needle lung biopsy

Secondary Outcome Measures

Full Information

First Posted
May 4, 2018
Last Updated
May 15, 2018
Sponsor
University Hospital, Akershus
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1. Study Identification

Unique Protocol Identification Number
NCT03526640
Brief Title
Computed Tomography (CT) Guided Lung Biopsy With Plug
Official Title
Computed Tomography (CT) Guided Lung Biopsy With Plug - Evaluation of Safety and Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 4, 2018 (Actual)
Primary Completion Date
August 4, 2020 (Anticipated)
Study Completion Date
August 4, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Computed Tomography, Biopsy, Pneumothorax, Chest Tube, Plug

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Block randomized design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
560 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Plug Arm
Arm Type
Experimental
Arm Description
Participants randomized for plug arm will be treated with a plug after CT guided is conducted.
Arm Title
Non Plug arm
Arm Type
No Intervention
Arm Description
No Intervention, i.a. CT guided biopsy without plug.
Intervention Type
Device
Intervention Name(s)
The BioSentry Tract Sealant System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the rate of chest tube
Description
Evaluate the rate of chest tube placement after percutaneous transthoracic needle lung biopsy
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Provide written informed consent prior to any study related procedure Male or female, aged ≥18 years or older 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haseem Ashraf, Associate professor, PhD
Phone
0047 67964572
Email
ashr@ahus.no
Facility Information:
Facility Name
Haseem Ashraf
City
Lørenskog
State/Province
Select A State
ZIP/Postal Code
1476
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haseem Ashraf, Associate professor, PhD
Phone
0047 6796572
Email
ashr@ahus.no

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20656223
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.
Results Reference
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PubMed Identifier
27826786
Citation
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.
Results Reference
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PubMed Identifier
27870824
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.
Results Reference
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Computed Tomography (CT) Guided Lung Biopsy With Plug

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