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Gravity vs. Vacuum Drainage Systems for Pleural Effusion (NEWTON Trial)
Seattle, WA
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
Must not have
Respiratory failure
Inability to follow-up for appointments/protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-ipc placement, 12 weeks post ipc placement or time of pleurodesis
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether gravity drainage or suction drainage is better for people with a debilitating complication of end stage cancer.
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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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am experiencing respiratory failure.
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I can attend all required appointments.
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I have painful bone metastases in my ribs or chest area.
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I have had a chemical treatment to close the space in my chest previously.
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I am worried I might have an infection in the lining of my lungs.
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My chest fluid can't be drained well due to trapped pockets.
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I have a condition that prevents my blood from clotting properly.
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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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in chest pain as assessed by Visual Analog Scale (VAS)
Secondary study objectives
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Find a Location
Closest Location:Northwest Community Healthcare· Arlington Heights, IL· 298 miles
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,361 Previous Clinical Trials
15,160,280 Total Patients Enrolled
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255 Patients Enrolled for Pleural Effusion
Rocket Medical plcOTHER
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Swedish Medical CenterOTHER
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Medical University of South CarolinaOTHER
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University of OxfordOTHER
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2,413 Patients Enrolled for Pleural Effusion
Vanderbilt University Medical CenterOTHER
919 Previous Clinical Trials
938,546 Total Patients Enrolled
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298 Patients Enrolled for Pleural Effusion
Northwest Community HealthcareUNKNOWN
1 Previous Clinical Trials
450 Total Patients Enrolled
Lonny Yarmus, DOPrincipal InvestigatorJohns Hopkins University
5 Previous Clinical Trials
663 Total Patients Enrolled
1 Trials studying Pleural Effusion
95 Patients Enrolled for Pleural Effusion
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer diagnosis was confirmed with a tissue sample.I am experiencing respiratory failure.I can attend all required appointments.I am scheduled to get an IPC placed within 10 days of joining.Unable to take care of a tube in the chest used for draining fluid.I have fluid buildup in my chest that is cancer-related.Your doctor expects you to live for less than 30 days, but if you are receiving care from a hospice program, you can still participate.I have painful bone metastases in my ribs or chest area.I am older than 17 years.I have had a chemical treatment to close the space in my chest previously.There is enough fluid shown on the ultrasound for the safe insertion of an IPC (indwelling pleural catheter).I have recurring fluid buildup in my chest due to cancer that has spread.I am worried I might have an infection in the lining of my lungs.My chest fluid can't be drained well due to trapped pockets.I felt better breathing after fluid was drained from my chest.I had chest surgery or injury causing long-term pain within the last 2 months.You currently have a catheter in the opposite side of your chest.I have a condition that prevents my blood from clotting properly.I need a chest drain for fluid buildup due to cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Vacuum
- Group 2: Gravity
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.