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Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source

NCT02843945 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-06-17

No results posted yet for this study

Summary

Initial study to evaluate local control and the preferred method of attachment of the CivaSheet in the setting of suspected close or positive margins at the time of surgical tumor removal.

Conditions

Interventions

DEVICE

Directional Brachytherapy Source Implant

The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiaiton source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.

Sponsors & Collaborators

  • CivaTech Oncology

    lead INDUSTRY

Principal Investigators

  • Joshua Meyer, MD · Fox Chase Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-31
Primary Completion
2027-10-29
Completion
2028-10-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02843945 on ClinicalTrials.gov