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

Description

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 Start Date

August 2014

Estimated Completion Date

August 2017

Interventions

  • Device: BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug
  • Other: ABPI

Specialties

  • Pulmonology: Lung/Thoracic Oncology
  • Oncology: Lung/Thoracic Oncology
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • Lung Biopsy
  • Pneumothorax

Study ID

Memorial Sloan-Kettering Cancer Center -- 14-141

Status

Unknown

Trial ID

NCT02224924

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

600

Sponsor

Memorial Sloan-Kettering Cancer Center

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
  • Needle path without transgression of pleural fissure is possible
  • Coaxial biopsy technique using Angiotech 19-Gauge introducer needle

Exclusion Criteria

  • Nodule less than 1.5 cm distance from visceral pleura
  • Passage through non-aerated lung or tissue
  • Needle path transgressing pleural fissure or bleb
  • Coaxial technique not needed
  • More than 1 biopsy on the same side requiring more than 1 pleural puncture
  • History of prior ipsilateral lung interventions including:
  • Prior biopsy of the same lesion
  • Chest tube placement
  • Surgery
  • Pleurodesis
  • Radiation treatment

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
Memorial Sloan Kettering West Harrison - West Harrison, New York 28.7 miles Majid Maybody MD 212-639-2793 None
Memorial Sloan Kettering Cancer Center - New York, New York 50.7 miles Majid Maybody MD 212-639-2793 None

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