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NCT03611543 · ClinicalTrials.gov registry record
Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle
A clinical trial, sponsored by Hologic.
- Completed
- Registry status
- 443
- Enrollment target
NCT03611543: Completed study, sponsored by Hologic.
NCT03611543 is a clinical trial that has completed, run by Hologic. The registered enrollment target is 443 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03611543 has completed, sponsored by Hologic.
- COMPLETED
- Registry status
- 443 participants
- Enrollment target
Study 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.
Primary Outcome
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'.
Interventions
- DEVICE Standard of Care Flat Paddle
- DEVICE Investigational Curved Paddle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 443 participants |
| Start Date | 2016-10-20 |
| Est. Completion | 2018-06-18 |
What the finished NCT03611543 record still lists
NCT03611543 is an observational study that tracks outcomes without assigning an intervention. The registered 443 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Standard of Care Flat Paddle is the first listed.
NCT03611543 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03611543 about?
NCT03611543 is a clinical study titled "Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle". 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 patien...
What is the current status of trial NCT03611543?
This trial is currently completed. The enrollment target is 443 participants. The study started on 2016-10-20. Estimated completion is 2018-06-18.
What interventions are being tested in trial NCT03611543?
The interventions under investigation include: Standard of Care Flat Paddle (DEVICE), Investigational Curved Paddle (DEVICE).
Who is sponsoring clinical trial NCT03611543?
This trial is sponsored by Hologic, which has 21 total clinical trials registered on ClinicalTrials.gov.
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