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

Part of paid clinical trials in Stamford, Connecticut.

Sponsor
Hologic, Inc.
Study ID
NCT03611543
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
25 Years - N/A
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Oct 20, 2016
Status verified
May 2025
Primary completion
Jun 18, 2018
Completion
Jun 18, 2018

Study Design

Enrollment
443 participants (actual)

Arms

  • Arm: 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'.
  • Arm: 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'.

Primary Outcome Measure

Subject Comfort [ Time Frame: 1 day (Day of procedure, No follow-up) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Stamford HospitalStamfordConnecticut06902-
Elizabeth Wende Breast ClinicRochesterNew York14620-
Solis MammagroaphyAddisonTexas75001-
TOPS Comprehensive Breast CenterHoustonTexas77090-

Find similar trials in Stamford, CT

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Stamford Hospital· Stamford, CTElizabeth Wende Breast Clinic· Rochester, NYSolis Mammagroaphy· Addison, TXTOPS Comprehensive Breast Center· Houston, TX

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