SHIELD
Accelerated Partial Breast Radiotherapy Study of a Personalized Holder for Prone Breast Immobilization to Enhance Local Delivery
Sponsor study identifier
interventional
30
1 country
1
Study Start
July 2, 2026
Actual (reported)Primary Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2, 2026
Actual (reported)July 7, 2026
Actual (reported)July 17, 2026
Actual (reported)July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Radiotherapy time includes patient positioning and treatment. Patient positioning accuracy is measured though displacement via Tattoos and Image-Guided Radiation Therapy imaging
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)
Patients' comfort (questionnaires)
Treatment set-up (up to 21 days) and study treatment (10 days)
Evaluate ease of use and overall satisfaction of using the VENUS SHELL (questionnaires)
Study treatment (10 days)
In-vivo dosimetry measured with thermoluminescent dosimeters (TLDs)
Radiotherapy treatment first session, up to last session (10 days)
VENUS SHELL™ is used for radiotherapy planning and radiotherapy tratment (Accelerated Partial Breast Radiotherapy)
VENUS SHELL™ is used for Accelerated Partial Breast Irradiation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
NYU Grossman School of Medicine
New York, New York, 10016, United States
Naamit Gerber, MD
NYU Langone Health
First Submitted
July 7, 2026
First Posted
July 17, 2026
Study Start
July 2, 2026
Actual (reported)Primary Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 23, 2026
Record last verified: 2026-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: