NCT02224924

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
454

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2014

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 22, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2014

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 30, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2023

Enrollment Period

8.4 years

First QC Date

August 22, 2014

Results QC Date

January 5, 2024

Last Update Submit

January 5, 2024

Conditions

Lung Biopsy

Keywords

Experimental: autologous blood patch injection (ABPI)Experimental: BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug14-141

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 hours post procedure

Study Arms (2)

autologous blood patch injection (ABPI)

ACTIVE COMPARATOR
Other: ABPI

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

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

Interventions

ABPIOTHER

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.

autologous blood patch injection (ABPI)
BioSentry (formerly known as Bio-Seal) hydrogel Tract PlugDEVICE

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.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

  • 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.

    PMID: 30480487DERIVED

Related Links

Results Point of Contact

Title
Dr. Amgad Moussa MD
Organization
Memorial Sloan Kettering Cancer Center
moussaa@mskcc.org
212-639-3690

Study Officials

  • Amgad Moussa, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2014

First Posted

August 25, 2014

Study Start

August 21, 2014

Primary Completion

January 11, 2023

Study Completion

January 11, 2023

Last Updated

January 30, 2024

Results First Posted

January 30, 2024

Record last verified: 2023-01

Locations

US(2)