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NCT03669003
Gelfoam to Prevent Pneumothorax After Lung Biopsy
Phase 2 trial testing Gelfoam slurry in Pneumothorax Iatrogenic Postprocedural. Withdrawn.
1 December 2019
Quick facts
| Lead sponsor | University of Miami |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Start date | 1 December 2018 |
| Primary completion | 1 December 2019 |
| Estimated completion | 1 December 2019 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Gelfoam slurry — full drug profile →
- CT-guided percutaneous lung biopsy
Conditions studied
- Pneumothorax Iatrogenic Postprocedural — all drugs for Pneumothorax Iatrogenic Postprocedural →
Sponsor
University of Miami
Who can join
Adults 18 to 80, any sex, with Pneumothorax Iatrogenic Postprocedural. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03669003 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Miami
- Last refreshed: 30 April 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03669003.
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