Computed Tomography (CT) Guided Lung Biopsy With Plug

U

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)

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.

Trial contacts and locations

1

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Central trial contact

Haseem Ashraf, Associate professor, PhD

Data sourced from clinicaltrials.gov

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