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

Primary Purpose

Lung Biopsy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ABPI
BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Biopsy focused on measuring Experimental: autologous blood patch injection (ABPI), Experimental: BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug, 14-141

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Westchester
  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

autologous blood patch injection (ABPI)

BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug

Arm Description

Outcomes

Primary Outcome Measures

the rate of pneumothorax
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.

Secondary Outcome Measures

Full Information

First Posted
August 22, 2014
Last Updated
January 11, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02224924
Brief Title
Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures
Official Title
Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 21, 2014 (Actual)
Primary Completion Date
January 11, 2023 (Actual)
Study Completion Date
January 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Biopsy
Keywords
Experimental: autologous blood patch injection (ABPI), Experimental: BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug, 14-141

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
autologous blood patch injection (ABPI)
Arm Type
Active Comparator
Arm Title
BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
ABPI
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug
Intervention Description
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.
Primary Outcome Measure Information:
Title
the rate of pneumothorax
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amgad Moussa, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30480487
Citation
Maybody M, Muallem N, Brown KT, Moskowitz CS, Hsu M, Zenobi CL, Jihad M, Getrajdman GI, Sofocleous CT, Erinjeri JP, Covey AM, Brody LA, Yarmohammadi H, Deipolyi AR, Bryce Y, Alago W, Siegelbaum RH, Durack JC, Gonzalez-Aguirre AJ, Ziv E, Boas FE, Solomon SB. Autologous Blood Patch Injection versus Hydrogel Plug in CT-guided Lung Biopsy: A Prospective Randomized Trial. Radiology. 2019 Feb;290(2):547-554. doi: 10.1148/radiol.2018181140. Epub 2018 Nov 27.
Results Reference
derived
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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