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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
Male or female, at least 18 years of age, inclusive.
There is histocytological confirmation of pleural malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
Study 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
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 30 days, 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 30 days, 90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants Undergoing Accelerated Pleurodesis
Secondary outcome measures
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 moreTrial 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.
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,351 Previous Clinical Trials
3,409,542 Total Patients Enrolled
Scott ShoferPrincipal InvestigatorDuke University
1 Previous Clinical Trials
20 Total Patients Enrolled
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