MedTrace Logo

Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System

NCT03831386 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-12-17

No results posted yet for this study

Summary

Malignant pleural effusion remains a debilitating complication of end stage cancer, which can be greatly improved by the introduction of the indwelling tunneled pleural catheter (IPC). However, there is no standard of care regarding drainage and limited data on the utility of different drainage techniques. In addition, many patients develop discomfort and chest pain during drainage. The investigators propose to evaluate gravity drainage and suction drainage on quality of life measures and outcomes.

Conditions

  • Pleural Effusion

Interventions

PROCEDURE

Vacuum-Based IPC

An indwelling pleural catheter is placed inside the chest cavity to drain fluid from around the lungs. One end remains inside the body while the other drains via suction.

PROCEDURE

Gravity-Based IPC

An indwelling pleural catheter is placed inside the chest cavity to drain fluid from around the lungs. One end remains inside the body while the other drains via gravity.

Sponsors & Collaborators

  • Rocket Medical plc

    collaborator OTHER

  • Swedish Medical Center

    collaborator OTHER

  • Medical University of South Carolina

    collaborator OTHER

  • University of Oxford

    collaborator OTHER

  • Vanderbilt University Medical Center

    collaborator OTHER

  • Northwest Community Healthcare

    collaborator UNKNOWN

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Lonny Yarmus, DO · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT03831386 on ClinicalTrials.gov