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Sclerosing Agent

Talc instilled via tunneled pleural catheter combined with standard daily drainage for Malignant Pleural Effusion

Phase 4
Waitlist Available
Led By Scott Shofer
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether draining cancer-related pleural effusions more frequently, using a talc-instilled pleural catheter, leads to better outcomes than the standard daily drainage method.

Eligible Conditions
  • Malignant Pleural Effusion

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 30 days, 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 30 days, 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Dyspnea as Measured by Questionnaire
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days
Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days
+1 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: Talc instilled via tunneled pleural catheter combined with standard daily drainageActive Control1 Intervention
This arm consists of eligible participants who are randomized to the Talc arm and would receive Talc therapy instilled into the pleural catheter.
Group II: Standard daily drainageActive Control1 Intervention
This arm consists of eligible participants who are randomized to control group and would not receive any intervention.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,452 Previous Clinical Trials
2,971,772 Total Patients Enrolled
Scott ShoferPrincipal InvestigatorDuke University
1 Previous Clinical Trials
20 Total Patients Enrolled
~1 spots leftby Nov 2025
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