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NCT03085004 · ClinicalTrials.gov registry record · Phase 3

CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts

A Phase 3 study of Pancreatic Cyst and EUS-FNA, sponsored by Milton S. Hershey Medical Center.

Active
Registry status
Phase 3
Development phase
75
Enrollment target
2
Study locations

NCT03085004 is a Phase 3 study of Pancreatic Cyst and EUS-FNA that is active but no longer recruiting, run by Milton S. Hershey Medical Center. The registered enrollment target is 75 participants, below the 546-participant average among 18 other Pancreatic Cyst trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT03085004, a Phase 3 study of Pancreatic Cyst and EUS-FNA, is active but no longer recruiting, sponsored by Milton S. Hershey Medical Center.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
75 participants
Enrollment target
2
Study locations

Study Summary

The purpose of this study is to evaluate the efficacy and safety of chemotherapeutic pancreatic cyst ablation using ethanol lavage followed by the infusion of a dual-agent chemotherapeutic cocktail (paclitaxel + gemcitabine) compared with alcohol-free saline lavage followed by infusion of the same dual-agent chemotherapeutic cocktail (paclitaxel + gemcitabine) for the ablation of pancreatic cystic neoplasms using endoscopic ultrasound guided fine needle infusion (EUS-FNI) for agent delivery.

Conditions Studied

Interventions

  • DRUG Normal saline
  • DRUG Ethanol
  • DRUG Paclitaxel + Gemcitabine admixture

Study Locations (2)

Indiana

  • Indiana University Health University Hospital - Indianapolis

Pennsylvania

  • Penn State Health Milton S. Hershey Medical Center - Hershey

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2019-04-12
Est. Completion 2026-02-01
Phase Phase 3

Sponsor

Milton S. Hershey Medical Center

396 total trials

What the Registry Record Tells You About NCT03085004

The ClinicalTrials.gov registry entry for NCT03085004 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 546-participant average among 18 other Pancreatic Cyst trials with a reported enrollment target (86% lower). The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Pancreatic Cyst appearing as the primary indexed condition, and to 3 interventions - of which Normal saline is the first listed.

NCT03085004 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Indiana, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT03085004 about?

NCT03085004 is a clinical study titled "CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts". The purpose of this study is to evaluate the efficacy and safety of chemotherapeutic pancreatic cyst ablation using ethanol lavage followed by the infusion of a dual-agent chemotherapeutic cocktail (paclitaxel + gemcitabine) compared with alcohol-free saline lavage followed by infusion of the same d...

What is the current status of trial NCT03085004?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2019-04-12. Estimated completion is 2026-02-01.

What conditions does trial NCT03085004 study?

This clinical trial studies the following conditions: Pancreatic Cyst, EUS-FNA.

What interventions are being tested in trial NCT03085004?

The interventions under investigation include: Normal saline (DRUG), Ethanol (DRUG), Paclitaxel + Gemcitabine admixture (DRUG).

Who is sponsoring clinical trial NCT03085004?

This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03085004 being conducted?

This trial has 2 study locations across Indiana, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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