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Gelfoam to Prevent Pneumothorax After Lung Biopsy

NCT03669003 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-04-30

No results posted yet for this study

Summary

Lung cancer is the deadliest of all cancers, and its incidence is on the rise. The importance of accurate and efficient lung biopsy without complications will only increase in importance going forward. Pneumothorax is a common complication of CT-guided lung biopsy. The purpose of this study is to assess the efficacy of using Gelfoam slurry in preventing pneumothorax from lung biopsy in a randomized controlled trial. Gelfoam (Pfizer, New York, NY, USA) is gelatin product approved by the Food and Drug Administration (FDA) for hemostasis during various procedures.

In the study group, the needle track will be laced with Gelfoam slurry following biopsy, and will be compared to standard lung biopsy without any other interventions. Both groups will be followed up with chest x-ray for pneumothorax.

Conditions

  • Pneumothorax Iatrogenic Postprocedural

Interventions

BIOLOGICAL

Gelfoam slurry

Approximately 1-2cc of Gelfoam slurry will be used to lace the needle track.

PROCEDURE

CT-guided percutaneous lung biopsy

Biopsy of a lung nodule under CT guidance.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Prasoon Mohan, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2019-12-01
Completion
2019-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03669003 on ClinicalTrials.gov