Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures

January 5, 2024 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this study is to compare two methods that are currently used at the end of a CT guided lung biopsy to close the hole on the surface of the lung in order to minimize the chance of air leaking out of the hole. The two techniques consist of either injecting a very small amount of your the blood called a blood patch into the biopsy hole or injecting a gel-based FDA approved artificial plug called BioSentry that will eventually get absorbed into the body.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will determine the rate of all pneumothoraces and those pneumothoraces requiring treatment following percutaneous lung biopsy in patients who have received ABPI or BioSentry at the end of the biopsy procedure. The data collected will be used to determine if there is equal effectiveness in the reduction of pneumothorax rates from both interventions.

Study Type

Interventional

Enrollment (Actual)

454

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥18 years of age
  • Referred for CT guided biopsy of lung lesion
  • Target lesion of any size
  • Target lesion located 1.5 cm or more away from visceral pleura based on the needle path
  • Skin thickness ≤7 cm (from skin to pleura)
  • Needle path without transgression of pleural fissure bleb, or bulla is possible
  • Coaxial biopsy technique using Angiotech 19-Gauge introducer needle
  • Needle length ≤15

Exclusion Criteria:

  • Passage through non-aerated lung or tissue
  • More than 1 biopsy on the same side requiring more than 1 pleural puncture
  • History of prior ipsilateral lung interventions including:
  • Chest tube placement
  • Surgery
  • Pleurodesis
  • Radiation treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: autologous blood patch injection (ABPI)
Other: ABPI
If the patient was assigned to the ABPI group, a blood patch will be administered using the clotted blood in the syringe obtained at the beginning of the procedure. The guiding needle will be retracted up to 1.5-2 cm from the pleural surface, and the blood will be injected steadily and gently as the needle is pulled back out of the pleura. Injection will stop when the operator feels the needle is in subcutaneous tissues.
Experimental: BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug
Device: BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug
If the patient is assigned to BioSentry group, using the manufacturer's deployment device the introducer needle is positioned so that the tip is at least 1.5 cm deep to the visceral pleura. The coaxial introducer needle hub will be prehydrated with a drop of saline, the BioSentry plug housing will be mated and locked to the hub and the plug will be deployed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Rate of Pneumothorax
Time Frame: 2 hours post procedure
within 2 hours following biopsy. Pneumothorax is observed on post procedure CT scan or on follow-up chest radiographs while the patient is in the recovery room, according to standard of care.
2 hours post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Amgad Moussa, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2014

Primary Completion (Actual)

January 11, 2023

Study Completion (Actual)

January 11, 2023

Study Registration Dates

First Submitted

August 22, 2014

First Submitted That Met QC Criteria

August 22, 2014

First Posted (Estimated)

August 25, 2014

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-141

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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