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An Efficacy Study of the Xoft® Axxent® eBx® IORT System® "Lite"

NCT04349111 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-08-02

No results posted yet for this study

Summary

The purpose of this trial is to assess the efficacy of the Xoft Axxent eBx System when used for single-fraction IORT in early stage breast cancer. A comparison will be made to the current standard of care, whole breast irradiation (WBI), in women with early stage breast cancer.

Conditions

  • Invasive Ductal Carcinoma
  • Ductal Carcinoma In Situ

Interventions

RADIATION

Intra-operative Radiation Therapy - IORT

Single dose of 20 Gy

Sponsors & Collaborators

  • Icad, Inc.

    collaborator INDUSTRY

  • Xoft, Inc.

    lead INDUSTRY

Principal Investigators

  • A. M. Nisar Syed, MD · Long Beach Memorial Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2033-12-31
Completion
2034-06-30
FDA Device
Yes

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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 NCT04349111 on ClinicalTrials.gov