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Computed Tomography (CT) Guided Lung Biopsy With Plug

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ClinicalTrials.gov Identifier: NCT03526640
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Haseem Ashraf, University Hospital, Akershus

Brief Summary:

Protocol Title:

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


Condition or disease Intervention/treatment Phase
Computed Tomography, Biopsy, Pneumothorax, Chest Tube, Plug Device: The BioSentry Tract Sealant System Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Block randomized design
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Computed Tomography (CT) Guided Lung Biopsy With Plug - Evaluation of Safety and Efficacy
Actual Study Start Date : May 4, 2018
Estimated Primary Completion Date : August 4, 2020
Estimated Study Completion Date : August 4, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy CT Scans

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.



Primary Outcome Measures :
  1. Evaluate the rate of chest tube [ Time Frame: 2 years ]
    Evaluate the rate of chest tube placement after percutaneous transthoracic needle lung biopsy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526640


Contacts
Contact: Haseem Ashraf, Associate professor, PhD 0047 67964572 ashr@ahus.no

Locations
Norway
Haseem Ashraf Recruiting
Lørenskog, Select A State, Norway, 1476
Contact: Haseem Ashraf, Associate professor, PhD    0047 6796572    ashr@ahus.no   
Sponsors and Collaborators
University Hospital, Akershus

Publications:
Responsible Party: Haseem Ashraf, Associate professor, PhD, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT03526640     History of Changes
Other Study ID Numbers: AHUS plug study 001
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases