Trial results evaluating an investigational curved mammography paddle for breast cancer screening were posted on 2025-05-21. The study found a significant improvement in patient comfort with the investigational paddle, reporting a mean comfort score of 2.6 on a scale compared to 4.0 for the standard paddle, with a p-value of 0.0001.
Background
Mammography is a crucial tool for breast cancer screening and early detection. However, the compression required during mammography can cause discomfort or pain for many patients, potentially deterring adherence to screening recommendations. This study aimed to investigate whether an investigational curved paddle could enhance patient comfort during breast compression without compromising image quality, and potentially increase the amount of breast tissue captured during the procedure.
Trial design
This study enrolled 443 subjects to evaluate patient comfort and image quality. The trial focused on individuals undergoing breast cancer screening. It compared an investigational curved mammographic paddle against a standard flat mammographic paddle. The primary goal was to determine if the investigational paddle could lead to an overall reduction in pain without a loss in image quality, and potentially increase tissue capture.
Key results
The study reported on several key measurements:
- Subject Comfort:
- For the INVESTIGATIONAL paddle group, the mean comfort score was 2.6 on a scale.
- For the STANDARD OF CARE paddle group, the mean comfort score was 4.0 on a scale.
- Breast Tissue Coverage:
- Counts of participants related to breast tissue coverage measurements included 69, 162, and 157 participants in the "All Enrolled Subjects" group.
- Overall Determination of Image Quality:
- Counts of participants related to overall image quality determination included 27, 330, and 63 participants in the "All Enrolled Subjects" group.
A key analysis using the Wilcoxon Rank-Sum test reported a p-value of 0.0001 for subject comfort, indicating a statistically significant difference between the investigational and standard paddles.
What this means
The statistically significant improvement in subject comfort (p-value of 0.0001) with the investigational curved paddle suggests a potential benefit for patients undergoing mammography for breast cancer screening. Reducing discomfort could enhance the patient experience and potentially improve adherence to recommended screening schedules. While the study also collected data on breast tissue coverage and image quality, specific comparative results or statistical analyses for these outcomes were not detailed in the provided key measurements and analyses beyond participant counts. The primary finding highlights the investigational paddle's potential to make mammography a more comfortable experience.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03611543, titled "Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle", were posted on 2025-05-21 on clinicaltrials.gov.