Lung Biopsy Clinical Trial
Official title:
Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures
Verified date | January 2023 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 454 |
Est. completion date | January 11, 2023 |
Est. primary completion date | January 11, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Westchester | Harrison | New York |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04415255 -
Novel Use of Extrapleural Autologous Blood Injection in CT-guided Percutaneous Lung Biopsy
|
N/A | |
Withdrawn |
NCT04039529 -
Novel Guidance Device for Image Fusion and Needle Guidance in Lung, Liver or Kidney Biopsy
|
N/A |