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Gravity Thoracentesis for Thoracentesis

N/A
Recruiting
Led By Horianna Grosu, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of a symptomatic moderate or large free-flowing (non-septated) pleural effusion based on specific criteria from chest radiograph, CT-scan, or ultrasound
Referral to pulmonary services for large-volume thoracentesis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial will compare chest discomfort during therapeutic thoracentesis between two groups, one using gravity and one using suction.

Who is the study for?
This trial is for adults (18+) needing large-volume thoracentesis due to moderate or large free-flowing pleural effusions, as shown by chest X-ray or CT scan. It's not for those just needing a diagnostic procedure, with septated effusions, unable to sit up, unable to consent, having severe coagulopathy or hemodynamic instability.Check my eligibility
What is being tested?
The GRAWITAS Study compares two methods of removing excess fluid from the chest: one using gravity and the other using wall suction during thoracentesis. The goal is to see which method causes less discomfort. Participants are randomly assigned and blinded to their treatment group.See study design
What are the potential side effects?
Potential side effects include discomfort during the procedure. Since it's a comparison of techniques rather than drugs, traditional medication side effects aren't expected; however, general risks associated with thoracentesis may apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a significant fluid buildup in my chest that causes symptoms.
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I have been referred for a procedure to remove fluid from my chest.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The overall procedural chest pain questionnaire

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2: Gravity Thoracentesis.Experimental Treatment2 Interventions
treatment techniques (gravity ) is a standard of care and used for draining fluid around the lung.
Group II: Group 1: Standard Suction ThoracentesisExperimental Treatment2 Interventions
treatment techniques suction is a standard of care and used for draining fluid around the lung.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,093 Total Patients Enrolled
Horianna Grosu, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Gravity Thoracentesis Clinical Trial Eligibility Overview. Trial Name: NCT05131945 — N/A
Thoracentesis Research Study Groups: Group 1: Standard Suction Thoracentesis, Group 2: Gravity Thoracentesis.
Thoracentesis Clinical Trial 2023: Gravity Thoracentesis Highlights & Side Effects. Trial Name: NCT05131945 — N/A
Gravity Thoracentesis 2023 Treatment Timeline for Medical Study. Trial Name: NCT05131945 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~13 spots leftby Aug 2024