A Multi-site Prospective, Non Randomized Study Utilizing the Conture® Multi-Lumen Balloon (MLB) Breast Brachytherapy Applicator to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetric Success, Local Tumor Control, Cosmetic Outcome, Acute and Chronic Toxicity, and Clinical Scenarios for Optimal Use
Data collected during this study will include baseline patient demographics, information
related to the time of implant, radiation therapy details, and removal of the device as well
as recurrence data, cosmetic outcomes and toxicities. The patient's follow-up data will be
collected during the patient's standard follow-up visits.
Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dosimetric efficacy of the Contura™ MLB with the historical efficacy rate of a single central lumen balloon device.
Douglas W. Arthur, MD
Virginia Commonwealth University
United States: Institutional Review Board
|Virginia Commonwealth University||Richmond, Virginia|