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Gravity vs. Vacuum Drainage Systems for Pleural Effusion (NEWTON Trial)

N/A

Recruiting

Led By Lonny Yarmus, DO

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histocytological proof of pleural malignancy

Plans for placement of IPC within ten days of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-ipc placement, 12 weeks post ipc placement or time of pleurodesis

Awards & highlights

NEWTON Trial Summary

This trial is testing whether gravity drainage or suction drainage is better for people with a debilitating complication of end stage cancer.

Who is the study for?

This trial is for adults over 17 with malignant pleural effusion, who've felt better after draining fluid from the chest. They must be able to safely have a catheter inserted and manage its care. Excluded are those with certain conditions like bleeding disorders, recent chest surgeries or trauma, very short life expectancy, or current infections.Check my eligibility

What is being tested?

The study compares two ways of draining fluid buildup in the chest due to cancer: using gravity or vacuum suction through an indwelling tunneled pleural catheter (IPC). It aims to see which method improves quality of life and has better outcomes.See study design

What are the potential side effects?

Potential side effects may include discomfort and chest pain during drainage. The extent of these side effects could vary based on whether gravity or vacuum suction is used.

NEWTON Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer diagnosis was confirmed with a tissue sample.

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I am scheduled to get an IPC placed within 10 days of joining.

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I have fluid buildup in my chest that is cancer-related.

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I am older than 17 years.

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I have recurring fluid buildup in my chest due to cancer that has spread.

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I felt better breathing after fluid was drained from my chest.

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I need a chest drain for fluid buildup due to cancer.

NEWTON Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-ipc placement, 12 weeks post ipc placement or time of pleurodesis

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-ipc placement, 12 weeks post ipc placement or time of pleurodesis

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-ipc placement, 12 weeks post ipc placement or time of pleurodesis for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in chest pain as assessed by Visual Analog Scale (VAS)

Secondary outcome measures

Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea survey score

Change in SF 36-Item Health Survey score

Change in mean difference in chest pain as assessed by VAS

NEWTON Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: GravityExperimental Treatment1 Intervention

The pleural fluid will be drained using gravity drainage to a bag positioned at bedside. Participants in this arm will undergo Gravity-Based IPC.

Group II: VacuumActive Control1 Intervention

The pleural fluid will be drained by the syringe system with a one-way valve tubing system provided in the kit. Selection of the vacuum pressure will be at the discretion of the proceduralist, as per standard of care. Participants in this arm will undergo Vacuum-Based IPC.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,837,297 Total Patients Enrolled

2 Trials studying Pleural Effusion

255 Patients Enrolled for Pleural Effusion

Rocket Medical plcOTHER

4 Previous Clinical Trials

458 Total Patients Enrolled

4 Trials studying Pleural Effusion

458 Patients Enrolled for Pleural Effusion

Swedish Medical CenterOTHER

53 Previous Clinical Trials

8,094 Total Patients Enrolled

Media Library

Gravity-Based IPC (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03831386 — N/A

Pleural Effusion Research Study Groups: Vacuum, Gravity

Pleural Effusion Clinical Trial 2023: Gravity-Based IPC Highlights & Side Effects. Trial Name: NCT03831386 — N/A

Gravity-Based IPC (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03831386 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many healthcare facilities have implemented this trial?

"Patients for this medical study can be found at a number of sites, such as the Medical University of South carolina in Charleston, Vanderbilt University Medical Center in Nashville and Johns Hopkins Hospital in Baltimore. Additionally, there are 5 other locations available."

Answered by AI

Is it possible to still enroll in this research endeavor?

"After reviewing the information available on clinicaltrials.gov, it is clear that recruitment for this study is still active and ongoing. The trial was initially posted on January 31st 2019 and most recently updated on August 26th 2022."

Answered by AI

How many participants are currently being included in this clinical study?

"To ensure that this research trial is successful, 200 patients fitting the inclusion criteria must be recruited. Those eligible to participate reside in various locations including Medical University of South carolina in Charleston and Vanderbilt University Medical Center in Nashville."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System

2019. "Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03831386.