Recruiting

VENUS SHELL™

Sponsor:

HeroSupport SA

Code:

NCT07711847

Conditions

Invasive Breast Cancer Early Stages

Ductal Carcinoma In Situ, DCIS

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Not accepted

Interventions

VENUS SHELL™ immobilization device

Study Details

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

Conditions

Invasive Breast Cancer Early Stages

Ductal Carcinoma In Situ, DCIS

Study ID

NCT07711847

Start date

Jul, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Not accepted

INCLUSION Criteria:

  • Written informed consent according to ICH/GCP regulations before registration and prior to any study-specific procedures
  • Upfront breast conservative surgery
  • Radiotherapy planned within 12 weeks after surgery
  • ECOG/WHO performance status ≤2
  • Age ≥40 year

For invasive breast cancer only:

  • Staging pT1-T2, N0M0 (Tumor size ≤3 cm)
  • If no sentinel lymph node biopsy performed, patient must be clinically N0
  • Negative margins (no tumor on ink)

For ductal carcinoma in situ only:

  • Staging pTis (tumor size ≤3 cm)
  • Negative margins (≥2 mm)

EXCLUSION Criteria:

  • Patient of male sex
  • Inability to obtain informed consent or adhere to the CIP
  • Breast skin damage that could prevent VENUS SHELL™ usage according to protocol timeline (e.g. presence of any skin or soft tissue wound that failed to show evidence of progression towards healing, clinical signs of active infection at or immediately adjacent to the intended intervention site, etc.)
  • Known germline BRCA1/2 mutation
  • Unable to lay prone
  • Unable to undergo imaging by CT scan
  • Documented hypersensitivity or allergy to medical plasters, acrylonitrile butadiene styrene
  • Any serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may affect patient compliance or place the patient at high risk within the study.
  • Pregnancy or breast feeding
  • Claustrophobia
  • Patient with a body weight exceeding 120 kg
  • Patient with pendulous breasts that come into contact with the CT table, preventing adequate space for shell usage
  • Presence of any cardiac implantable electronic device (CIED), including but not limited to a pacemaker, implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT) device, or other electronically active implant.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VENUS SHELL™ arm

VENUS SHELL™ is used for radiotherapy planning and radiotherapy tratment (Accelerated Partial Breast Radiotherapy)

Interventions

VENUS SHELL™ immobilization device

VENUS SHELL™ is used for Accelerated Partial Breast Irradiation

Primary outcome measure

  • Feasibility outcome: Time (days) between surface scan data received by HeroSupport and arrival of the VENUS SHELL™ at the clinical site [ Time Frame: Treatment set-up (up to 21 days) ]
  • Performance outcomes: radiotherapy delivered within 15 minutes timeslot and patient positioning accuracy within 2 mm [ Time Frame: Study treatment (10 days) ]
  • Safety outcome: number of medical device-related Adverse Events as assessed by CTCAE v5.0 [ Time Frame: Through study completion (an average of 3 months) ]

Central Contacts and Locations

Central contacts

Giovanna Dipasquale

+41(0)783349987giovanna@herosupport.ch

Cristina Riccadonna

+41(0)223794650clinical@herosupport.ch

Locations

NYU Grossman School of Medicine

Recruiting

New York, New York, United States, 10016

Contacts

Lucia Greco

718-687-8702lucia.greco@nyulangone.org

Nadia Chowdhury

347-327-4988nadia.chowdhury@nyulangone.org

Principal Investigator:

Naamit Gerber, MD

More Information

Sponsor

HeroSupport SA

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Keywords

  • APBI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by HeroSupport SA on 2026-07-17.