Clinical trial · Observational
Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle
NCT03611543CI-TRIAL-00090011completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Investigational Curved Paddle | Device | — | UNRESOLVED |
| Standard of Care Flat Paddle | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- STANDARD OF CARE
- description
- 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'.
- interventionNames
- Device: Standard of Care Flat Paddle
- label
- INVESTIGATIONAL
- description
- 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'.
- interventionNames
- Device: Investigational Curved Paddle
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.