Computed Tomography (CT) Guided Lung Biopsy With Plug

  • days left to enroll
  • participants needed
  • sponsor
    University Hospital, Akershus
Updated on 3 March 2022
Accepts healthy volunteers


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


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

Condition Computed Tomography, Biopsy, Pneumothorax, Chest Tube, Plug
Treatment The BioSentry Tract Sealant System
Clinical Study IdentifierNCT03526640
SponsorUniversity Hospital, Akershus
Last Modified on3 March 2022


Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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