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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

454 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-21

Study Completion Date

2023-01-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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autologous blood patch injection (ABPI)

Group Type ACTIVE_COMPARATOR

ABPI

Intervention Type OTHER

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.

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No