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ACTIVE NOT RECRUITING Phase 3

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

NCT03085004 · View on ClinicalTrials.gov ↗

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

277 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03085004

The ClinicalTrials.gov registry entry for NCT03085004 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 277 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03085004 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Indiana, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03085004?

The interventions under investigation include: Normal saline (DRUG), Ethanol (DRUG), Paclitaxel + Gemcitabine admixture (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03085004?

This trial is sponsored by Milton S. Hershey Medical Center, which has 277 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial