CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Patient-Assisted Compression (PAC) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03456427
NCT03456427N/ACompleted

Patient-Assisted Compression in 3D - Impact on Image Quality and Workflow

GE Healthcare·interventional·Posted Mar 7, 2018·Updated Apr 5, 2019

In Brief

A clinical study evaluating Patient-Assisted Compression (PAC) and Technologist-Controlled (TC) Compression for Breast Cancer. Completed, enrolled 36 participants across 1 site.

Detailed Summary

Patient-assisted compression (PAC) allows the patient to participate in controlling the amount of compression force during mammography and is a personalized approach that has demonstrated successful reduction in discomfort experienced during mammography. General Electric Healthcare's Senographe Pristina, an innovative mammography platform that provides both two-dimensional (2D) and three-dimensional (3D) imaging capabilities, offers both standard and patient-assisted compression modes. This study will evaluate image quality and clinical workflow as it relates to use of PAC with the Senographe Pristina 3D.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 7, 2018
Enrollment StartJan 4, 2018
Primary CompletionJan 9, 2018
TodayJul 2, 2026
Enrollment to primary: 5 daysPosted 8.3 years ago

Interventions

Patient-Assisted Compression (PAC)device

The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views Craniocaudal (CC) \& Mediolateral Oblique (MLO).

Technologist-Controlled (TC) Compressiondevice

TC compression will be conducted per standard of care practices at the site.