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Personalized Prone Immobilization for Accelerated Partial Breast Radiotherapy

NCT07711847 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-17

No results posted yet for this study

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

Conditions

  • Invasive Breast Cancer Early Stages
  • Ductal Carcinoma In Situ, DCIS

Interventions

DEVICE

VENUS SHELL™ immobilization device

VENUS SHELL™ is used for Accelerated Partial Breast Irradiation

Sponsors & Collaborators

  • University Hospital, Geneva

    collaborator OTHER

  • MDSS

    collaborator UNKNOWN

  • HeroSupport SA

    lead INDUSTRY

Principal Investigators

  • Naamit Gerber, MD · NYU Langone Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-07-31
Completion
2027-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT07711847 on ClinicalTrials.gov