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Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer

NCT01851772 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-01-12

Study results available
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Summary

The purpose of this study is to evaluate the safety, performance and usability of the Xoft Axxent Electronic Brachytherapy System and Cervical Applicator as incorporated into the physician's current standard treatment practice and in replacement of high-dose-rate after-loaders using Iridium-192 or low-dose-rate Cesium treatments. Data will be collected on treatment delivery, safety, and acute toxicity.

Our hypothesis is that the treatment is safe as incorporated into the physician's current standard of practice.

Conditions

Interventions

DEVICE

Treatment with Electronic Brachytherapy

Sponsors & Collaborators

  • Icad, Inc.

    collaborator INDUSTRY

  • Xoft, Inc.

    lead INDUSTRY

Principal Investigators

  • Lowndes Harrison, MD · Gadsden Regional Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-06-30
Completion
2015-06-30

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 NCT01851772 on ClinicalTrials.gov