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NCT07186491 · ClinicalTrials.gov registry record · NA
Wearable Ultrasound Patch for Breast Imaging
A NA study, sponsored by Massachusetts General Hospital.
- Not yet
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT07186491: Clinical Trial NA study, sponsored by Massachusetts General Hospital.
NCT07186491 is a NA study that has not yet begun recruiting, run by Massachusetts General Hospital. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07186491, a NA study, has not yet begun recruiting, sponsored by Massachusetts General Hospital.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn if a wearable ultrasound (US) patch can provide reliable whole-breast imaging and accurately detect breast lesions in patients undergoing breast health evaluation. The main questions it aims to answer are: * How well does the US-patch detect breast lesions in breasts of different shapes, sizes, and tissue densities? * Are there any side effects or discomfort from using the US-patch? Researchers will compare results from the wearable US-patch to conventional ultrasound to see if the patch provides specific and sensitive findings. Participants will: * Have breast imaging performed with the wearable US-patch, which is applied directly to the breast and secured with a sports bra. * Use a guiding software application that helps correctly position the patch. * Complete the imaging session in less than 15 minutes, performed by study personnel.
Primary Outcome
The primary outcome will assess the diagnostic accuracy of the conformable US-patch device by comparing its breast lesion detection results to conventional handheld ultrasound (reference standard). Sensitivity and specificity will be calculated per lesion using true positive, false positive, true negative, and false negative determinations based on radiologist interpretation. This metric will serve as the main assessment of the device's performance in detecting breast anomalies across a range of
Interventions
- DEVICE Wearable Ultrasound Patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2026-04-01 |
| Est. Completion | 2027-03 |
| Phase | NA |
What is known before NCT07186491 opens enrollment
NCT07186491 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Wearable Ultrasound Patch is the first listed.
NCT07186491 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07186491 about?
NCT07186491 is a clinical study titled "Wearable Ultrasound Patch for Breast Imaging". The goal of this clinical trial is to learn if a wearable ultrasound (US) patch can provide reliable whole-breast imaging and accurately detect breast lesions in patients undergoing breast health evaluation. The main questions it aims to answer are: * How well does the US-patch detect breast lesion...
What is the current status of trial NCT07186491?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2026-04-01. Estimated completion is 2027-03.
What interventions are being tested in trial NCT07186491?
The interventions under investigation include: Wearable Ultrasound Patch (DEVICE).
Who is sponsoring clinical trial NCT07186491?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07186491's enrollment target sits among peer trials
50 1279th of 2000 higher than 622 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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