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Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®

NCT04033081 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-23

No results posted yet for this study

Summary

This patient study will determine the safety and toxicity of a permanently implantable brachytherapy source - CivaSheet® - which is designed to deliver a therapeutic dose of low dose rate (LDR) radiation with polymer encased Palladium-103. CivaSheet will be implanted in sarcoma patients with disease presenting in the retroperitoneum, abdomen, pelvis and trunk.

Conditions

  • Sarcoma

Interventions

DEVICE

CivaSheet

Implanting CivaSheet radiation therapy device at the time of surgery to irradiate surgical margin potentially preventing local recurrence

Sponsors & Collaborators

  • CivaTech Oncology

    lead INDUSTRY

Principal Investigators

  • Dian Wang, MD · Rush University Medical Center

  • Krisha Howell, MD · Michigan Healthcare Professionals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2027-01-31
Completion
2030-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04033081 on ClinicalTrials.gov