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COMPLETED NA

Study of iBreast, a Handheld Device to Detect Breast Abnormalities During Screening Visits for Breast Cancer

NCT04761055 · View on ClinicalTrials.gov ↗

Study Summary

This study will test the iBreastExam device to find out whether it can detect a mass or lump in the breast as accurately as a routine breast cancer screening examination. The iBreastExam is a handheld device that performs a painless electronic palpation (examination by touch) of the breast. The device is designed to detect breast abnormalities that may require breast imaging and additional clinical examination by a nurse or doctor. The iBreastExam device creates a color map of the breast, with red spots indicating areas that may be abnormal.

Conditions Studied

Interventions

  • OTHER Clinical Breast exam (CBE)
  • DEVICE iBreastExam device
  • DIAGNOSTIC_TEST mammogram

Study Locations (2)

New York

  • MSK at Ralph Lauren (All Protocol Activities) — New York
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York

Trial Details

FieldValue
Enrollment Target 309 participants
Start Date 2021-01-29
Est. Completion 2025-08-19
Phase NA

Sponsor

Memorial Sloan Kettering Cancer Center

2,280 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04761055

The ClinicalTrials.gov registry entry for NCT04761055 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 309 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 2,280 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Breast Screening appearing as the primary indexed condition, and to 3 interventions — of which Clinical Breast exam (CBE) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04761055 reports 2 study locations spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04761055 about?

NCT04761055 is a clinical study titled "Study of iBreast, a Handheld Device to Detect Breast Abnormalities During Screening Visits for Breast Cancer". This study will test the iBreastExam device to find out whether it can detect a mass or lump in the breast as accurately as a routine breast cancer screening examination. The iBreastExam is a handheld device that performs a painless electronic palpation (examination by touch) of the breast. The dev...

What is the current status of trial NCT04761055?

This trial is currently completed. It is a NA study. The enrollment target is 309 participants. The study started on 2021-01-29. Estimated completion is 2025-08-19.

What conditions does trial NCT04761055 study?

This clinical trial studies the following conditions: Breast Screening. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04761055?

The interventions under investigation include: Clinical Breast exam (CBE) (OTHER), iBreastExam device (DEVICE), mammogram (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04761055?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 2,280 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04761055 being conducted?

This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial