Trial Outcomes & Findings for Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle (NCT NCT03611543)

Last Updated: 2025-05-21

Results Overview

The Universal Pain Assessment Tool (UPAT) was used to assess each subject's comfort perception with each paddle (SOC and INV). The UPAT ranges from 0 to 10, where 0 represents 'no pain' and 10 'worst pain possible'.

Recruitment status

COMPLETED

Target enrollment

443 participants

Primary outcome timeframe

1 day (Day of procedure, No follow-up)

Results posted on

2025-05-21

Participant Flow

Subjects were recruited based on inclusion/exclusion criteria from protocol 16-03 at 4 clinical sites between October 2016 and June 2018.

This study involved subjects undergoing a mammogram exam (screening or diagnostic). All subjects were X-ray imaged using the standard of care (SOC) flat paddle and the investigational (INV) curved paddle. Thus, the subjects in the SOC group were the same as those in the INV group. A total of 443 subjects were initially enrolled. Of those, 14 did not complete the study.

Unit of analysis: Mammogram exams in total

Participant milestones

Participant milestones
Measure	Standard of Care Flat Paddle Subjects involved in this study underwent a screening routine mammogram or a diagnostic mammogram using the standard of care (SOC) flat paddle. A screening mammogram involved 4-image views (both breasts: LCC, LMO, RCC, RMLO) with the SOC paddle. A diagnostic mammogram involved 2-image views (CC and MLO) of the breast of interest with the SOC paddle.	Investigational Curved Paddle Subjects involved in this study underwent a screening routine mammogram or a diagnostic mammogram using the investigational (INV) curved paddle. A screening mammogram involved 2-image views (CC and MLO) in one of the breasts as determined by a randomization scheme. A diagnostic mammogram involved 2-image views (CC and MLO) of the breast of interest only.
Overall Study STARTED	443 443	443 443
Overall Study COMPLETED	429 429	429 429
Overall Study NOT COMPLETED	14 14	14 14

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard of Care Flat Paddle Subjects involved in this study underwent a screening routine mammogram or a diagnostic mammogram using the standard of care (SOC) flat paddle. A screening mammogram involved 4-image views (both breasts: LCC, LMO, RCC, RMLO) with the SOC paddle. A diagnostic mammogram involved 2-image views (CC and MLO) of the breast of interest with the SOC paddle.	Investigational Curved Paddle Subjects involved in this study underwent a screening routine mammogram or a diagnostic mammogram using the investigational (INV) curved paddle. A screening mammogram involved 2-image views (CC and MLO) in one of the breasts as determined by a randomization scheme. A diagnostic mammogram involved 2-image views (CC and MLO) of the breast of interest only.
Overall Study Withdrawal by Subject	4	4
Overall Study Physician Decision	1	1
Overall Study Protocol Violation	2	2
Overall Study Device failure	2	2
Overall Study Missing information	5	5

Baseline Characteristics

Subjects analyzed based on complete data set availability

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Enrolled Subjects n=429 Participants This study involves subjects undergoing a mammogram exam (screening or diagnostic). These subjects were X-ray imaged using the SOC and INV paddles to determine changes in their comfort level and establish a direct comparison between devices. This means the subjects in the SOC group are the same as those in the INV group. This section consolidates (combines) all the subjects enrolled as one group rather than two groups because we're evaluating both devices on the same subjects.
Age, Continuous	54.6 years STANDARD_DEVIATION 11 • n=5 Participants • Subjects analyzed based on complete data set availability
Sex: Female, Male Female	429 Participants n=5 Participants • Subjects analyzed based on complete data set availability
Sex: Female, Male Male	0 Participants n=5 Participants • Subjects analyzed based on complete data set availability
Race/Ethnicity, Customized White	374 Participants n=5 Participants
Race/Ethnicity, Customized African American/Black	29 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	20 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Indian/Persian	3 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants
Region of Enrollment United States	429 participants n=5 Participants
BI-RADS Breast Density Assessment Type A (Breasts are almost entirely fatty)	47 participants n=5 Participants
BI-RADS Breast Density Assessment Type B (Breasts are mainly fatty, with some scattered areas of dense tissue)	192 participants n=5 Participants
BI-RADS Breast Density Assessment Type C (Breasts are a mixture of fatty and dense tissue)	147 participants n=5 Participants
BI-RADS Breast Density Assessment Type D (Breasts are almost entirely dense)	31 participants n=5 Participants
BI-RADS Breast Density Assessment Blank (No breast density category was recorded for the subjects)	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day (Day of procedure, No follow-up)

Population: The number of participants analyzed per group differs from the number provided in the Participant Flow module (429). Two subjects' pain scores were unclear when imaged with the INV paddle. For this reason, the analysis was done by contemplating 427 subjects. Three subjects' pain scores were unclear when imaged with the INV paddle. For this reason, the analysis was done by contemplating 426 subjects.

Outcome measures

Outcome measures
Measure	INVESTIGATIONAL n=427 Participants All the subjects enrolled in this study will be under a routine screening mammogram or undergoing a diagnostic mammogram using the investigational (INV) curved paddle.	STANDARD OF CARE n=426 Participants All the subjects enrolled in this study will be under a routine screening mammogram or undergoing a diagnostic mammogram using the standard of care (SOC) flat paddle.
Subject Comfort	2.6 score on a scale Interval 2.3 to 2.6	4.0 score on a scale Interval 3.6 to 4.1

SECONDARY outcome

Timeframe: 1 Day (Day of procedure, No Follow-up)

Population: The number of participants analyzed per group differs from the number provided in the Participant Flow module (429). Technologists did not provide an answer to the question about preference for tissue coverage in 41 cases. For this reason, the analysis was done in 388 subjects only. The same 388 subjects are part of both groups: INV and SOC groups. Therefore, the results are shown combined in the data table.

An expert technologist evaluated the performance of the SOC and the INV paddles in 388 subjects. For each participant, the technologist answered which paddle was better at pulling in more breast tissue during imaging between SOC and INV (all subjects were imaged with both paddles during the same session). The technologist rated the paddles using a 5-point Likert scale, where -2 and -1 values mean that the SOC paddle performed better or slightly better, 0 means equal performance between paddles, and 2 and 1 mean that the INV performed better or slightly better than the SOC paddle. Note that different technologists were involved in the image acquisition. An acceptable tissue coverage for this study refers to having sufficient breast tissue (a balance between fatty and glandular tissue) in the image acquired so that any potential abnormalities can be effectively identified.

Outcome measures

Outcome measures
Measure	INVESTIGATIONAL n=388 Participants All the subjects enrolled in this study will be under a routine screening mammogram or undergoing a diagnostic mammogram using the investigational (INV) curved paddle.	STANDARD OF CARE All the subjects enrolled in this study will be under a routine screening mammogram or undergoing a diagnostic mammogram using the standard of care (SOC) flat paddle.
Breast Tissue Coverage Rate -2 or -1 (SOC better or slightly better than INV)	69 Participants	—
Breast Tissue Coverage Rate 2 or 1 ( INV better or slightly better than SOC)	157 Participants	—
Breast Tissue Coverage Rate 0 ( SOC equal INV)	162 Participants	—

SECONDARY outcome

Timeframe: 1 day (Day of procedure, No Follow-up)

Population: The number of participants analyzed per group differs from the number provided in the Participant Flow module (429). Data results related to image quality were unclear in nine subjects. For this reason, the analysis considered only 420 subjects. These 420 subjects are the same in both groups, INV and SOC, so the images can be comparable. Therefore, the results shown are combined in the data table.

An expert radiologist reviewed, side by side, 3D images acquired with the INV and the SOC paddles in 420 subjects. The radiologist rated the images using a 5-point Likert scale, where -2 and -1 values mean that the images acquired with the SOC paddle have better or slightly better quality, 0 means equal quality between the images, and 2 and 1 mean that the images acquired with the INV paddle have better or slightly better quality than the SOC paddle. To determine overall clinical image quality or image acceptability, the radiologist considered whether the images reviewed have fair lesion visibility (when a lesion is present), good breast tissue separations of structures, good breast tissue coverage, no artifacts due to patient motion, and can be used to determine breast tissue density. Note that not all the 420 images were reviewed by the same radiologist.

Outcome measures

Outcome measures
Measure	INVESTIGATIONAL n=420 Participants All the subjects enrolled in this study will be under a routine screening mammogram or undergoing a diagnostic mammogram using the investigational (INV) curved paddle.	STANDARD OF CARE All the subjects enrolled in this study will be under a routine screening mammogram or undergoing a diagnostic mammogram using the standard of care (SOC) flat paddle.
Overall Determination of Image Quality Rate 2 or 1 (INV better or slightly better than SOC)	63 Participants	—
Overall Determination of Image Quality Rate -2 or -1 (SOC better or slightly better than INV)	27 Participants	—
Overall Determination of Image Quality Rate 0 (SOC equal INV)	330 Participants	—

Adverse Events

All Enrolled Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Muhammad Waqas, Director of Global Clinical Affairs, BSH

Hologic, Inc.

Phone: (508) 263-8935

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place