Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle

NCT03611543 | Completed Results FDA Device

• 1 other identifier: 16-03
• Study Type: observational
• Target: 443
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this study is to evaluate patient comfort during compression with a standard flat mammographic paddle and an investigational curved paddle. This is a study that will be performed with x-ray imaging and will be used to determine if an overall reduction in pain can be appreciated in patients without loss in image quality as compared to the current standard mammogram. Another benefit of the curved paddle may be an increase of perceivable and measurable tissue capture.

Conditions

Breast Cancer

Keywords

Breast Cancer; Tomosynthesis; 3D Mammogram; Diagnostic Mammogram

Outcome Measures

Primary Outcomes (1)

• Subject Comfort

  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'.

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

Secondary Outcomes (2)

• Breast Tissue Coverage

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

• Overall Determination of Image Quality

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

Study Arms (2)

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. The Universal Pain Assessment Tool (UPAT) will be used to determine the comfort perception of each subject with the SOC paddle. The UPAT ranges from 0 to 10, where 0 represents 'no pain' and 10 'worst pain possible'.

Device: Standard of Care Flat Paddle

INVESTIGATIONAL

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. The Universal Pain Assessment Tool (UPAT) will be used to determine the comfort perception of each subject with the INV paddle. The UPAT ranges from 0 to 10, where 0 represents 'no pain' and 10 'worst pain possible'.

Device: Investigational Curved Paddle

Interventions

Standard of Care Flat Paddle DEVICE

X-Ray Mammogram Exam. Each screening subject will receive a 4-view 2D plus 3D combination imaging: Left Cranial Caudal (LCC), Left Medial Oblique (LMO), Right Cranial Caudal (RCC), and Right Medial Oblique (RMLO) with the current standard of care (SOC) flat paddle. Each diagnostic subject will have her prescribed diagnostic 2D plus 3D combination imaging (CC or MLO) with the SOC flat paddle. The image view (CC or MLO) will be based on the visibility of the area of interest for which the diagnostic imaging was ordered. The amount of compression applied in all mammograms will be to achieve tautness.

STANDARD OF CARE

Investigational Curved Paddle DEVICE

X-Ray Mammogram Exam. Each screening subject will receive a CC and an MLO in one of her breasts as determined by a randomization scheme with the investigational (INV) curved paddle. Each diagnostic subject will have her prescribed diagnostic 2D plus 3D combination imaging (CC or MLO) with the INV curved paddle. The image view (CC or MLO) will be based on the visibility of the area of interest for which the diagnostic imaging was ordered. The amount of compression applied in all mammograms will be to achieve tautness.

INVESTIGATIONAL

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women participating in the study will present for a screening or diagnostic imaging breast exam.

You may qualify if:

• Subject is female of any race and ethnicity
• Screening Subject is at least 40 years old, Diagnostic subjects are at least 25 years old
• Subject will be referred for a screening or a diagnostic work-up with tomosynthesis as part of the exam

You may not qualify if:

• Subjects who are pregnant or who think they may be pregnant
• Subjects lactating or presenting with discharge
• Women too large for the detector
• Subjects who cannot give informed consent

Sponsors & Collaborators

• Hologic, Inc.: lead

Study Sites (4)

Stamford Hospital

Stamford, Connecticut, 06902, United States

Location

Elizabeth Wende Breast Clinic

Rochester, New York, 14620, United States

Location

Solis Mammagroaphy

Addison, Texas, 75001, United States

Location

TOPS Comprehensive Breast Center

Houston, Texas, 77090, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Muhammad Waqas, Director of Global Clinical Affairs, BSH
• Organization: Hologic, Inc.

ClinicalResearch@Hologic.com

(508) 263-8935

Study Officials

• Muhammad Waqas

  Hologic, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: August 2, 2018
• Study Start: October 20, 2016
• Primary Completion: June 18, 2018
• Study Completion: June 18, 2018
• Last Updated: May 21, 2025
• Results First Posted: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)