Computed Tomography (CT) Guided Lung Biopsy With Plug

University Hospital, Akershus

Status: Unknown

Conditions: Computed Tomography, Biopsy, Pneumothorax, Chest Tube, Plug

Treatments: Device: The BioSentry Tract Sealant System

Study type: Interventional

Funder types: Other

Identifiers

NCT03526640

AHUS plug study 001

Details and patient eligibility

About

Protocol Title:

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

Full 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

Enrollment: 560 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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560 participants in 2 patient groups

Plug Arm

Experimental group

Description:

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

Treatment:

Device: The BioSentry Tract Sealant System

Non Plug arm

No Intervention group

Description:

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