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Life sciences · Interventional Study
ClinicalTrials.gov · September 23, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07711847). This is a study registration, not published results. Lead sponsor: HeroSupport SA. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Invasive Breast Cancer Early Stages, Ductal Carcinoma In Situ, DCIS. Interventions: DEVICE: VENUS SHELL™ immobilization device. Primary outcome measures: Feasibility outcome: Time (days) between surface scan data received by HeroSupport and arrival of the VENUS SHELL™ at the clinical site , Treatment set-up (up to 21 days); Performance outcomes: radiotherapy delivered within 15 minutes timeslot and patient positioning accuracy within 2 mm , Study treatment (10 days); Safety outcome: number of medical device-related Adverse Events as assessed by CTCAE v5.0 , Through study completion (an average of 3 months). Brief summary: The goal of this clinical trial is to find out whether using a personalized breast holder (called VENUS SHELL™) can improve positioning and patient comfort during prone radiotherapy (radiotherapy given while the patient lies on her stomach). The main goals of the study are: * To confirm that using the VENUS SHELL™ is safe and effective * To assess whether the VENUS SHELL™ helps deliver accurate radiation treatment in a faster and more comfortable way Participants will: * Attend a study visit before radiotherapy to have a breast surface scan (no radiation) and enable the production of their personalized VENUS SHELL™ * Use their VENUS SHELL™ during radiotherapy planning and treatment * Be asked to complete questionnaires about their comfort