Computed Tomography (CT) Guided Lung Biopsy With Plug

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

Protocol Title:

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

Study Overview

• Status: Recruiting
• Conditions: Computed Tomography, Biopsy, Pneumothorax, Chest Tube, Plug
• Intervention / Treatment: Device: The BioSentry Tract Sealant System

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

• Study Type: Interventional
• Enrollment (Anticipated): 560
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haseem Ashraf, Associate professor, PhD; Phone Number: 0047 67964572; Email: ashr@ahus.no

Study Locations

• Norway
  • Select A State
    • Lørenskog, Select A State, Norway, 1476
      • Recruiting
      • Haseem Ashraf
      • Contact: Haseem Ashraf, Associate professor, PhD; Phone Number: 0047 6796572; Email: ashr@ahus.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Akershus

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 4, 2018
• Primary Completion (ANTICIPATED): August 4, 2020
• Study Completion (ANTICIPATED): August 4, 2023

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (ACTUAL): May 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 16, 2018
• Last Update Submitted That Met QC Criteria: May 15, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax
• Other Study ID Numbers: AHUS plug study 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No