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NCT03591952: GRAVITAS

Gravity- Versus Suction-driven Large Volume Thoracentesis

Completed NA Last updated 14 March 2022
What this trial tests

NA trial testing Suction-Driven Thoracentesis in Pleural Effusion in 138 participants. Completed in 12 September 2019.

Timeline
1 August 2018
Primary endpoint
5 April 2019
12 September 2019

Quick facts

Lead sponsorVanderbilt University Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment138
Start date1 August 2018
Primary completion5 April 2019
Estimated completion12 September 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Vanderbilt University Medical Center

Who can join

18 and older, any sex, with Pleural Effusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Thoracentesis is a very common procedure, rarely associated with severe complications. One relatively common complication is chest discomfort, which is most of the time felt to be secondary to negative pleural pressures generated during the procedure. While most proceduralists use suction to drain the pleural fluid, some drain effusions by gravity only. The investigators propose to evaluate whether gravity-driven thoracentesis results in less discomfort for patients than suction-drive thoracentesis.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The Impact of Gravity vs Suction-driven Therapeutic Thoracentesis on Pressure-related Complications: The GRAVITAS Multicenter Randomized Controlled Trial.
    Lentz RJ, Shojaee S, Grosu HB, Rickman OB, et al · · 2020 · cited 16× · PMID 31711990 · DOI 10.1016/j.chest.2019.10.025
  2. Pragmatic Studies in Interventional Pulmonology: Two Steps Forward, One Step Back, but an Imminent Leap Forward. Introducing IPOG, the Interventional Pulmonary Outcome Group.
    Maldonado F, Yarmus L. · · 2019 · cited 5× · PMID 31233469 · DOI 10.1097/lbr.0000000000000575

Verify or expand the search:

Other recruiting trials for Pleural Effusion

Currently open trials in the same condition.

Other Vanderbilt University Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT03591952.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing