Using the Conture® Multi-Lumen Balloon to Deliver Accelerated Partial Breast Brachytherapy

NCT00699101 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2013-06-17

No results posted yet for this study

Summary

This multiple site, prospective, non-randomized study has been designed to compile information on the efficacy of the Contura™ MLB in delivering APBI in appropriately selected patients through evaluation of dosimetric success as compared with a single central lumen balloon device and through treatment outcomes.

Conditions

Interventions

DEVICE

Conture Multi-Lumen Balloon

Placement of the balloon in a separate procedure using ultrasound guidance after surgery for breast cancer.

Sponsors & Collaborators

  • C. R. Bard

    collaborator INDUSTRY
  • SenoRx, Inc.

    lead INDUSTRY

Principal Investigators

  • Douglas W. Arthur, MD · Virginia Commonwealth University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-03-31
Completion
2013-06-30

Countries

  • United States

Study Locations

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Entities

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 NCT00699101 on ClinicalTrials.gov