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Not yet recruiting NCT07388940

Pilot Study of MammoGRIP for Breast Positioning, Image Quality, and Patient Comfort in Mammography

No phase Interventional Mammography

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MammoGRIP.
Who it may be relevant to
Registry conditions: Mammography. Basic parameters: 40 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

To evaluate the effectiveness of MammoGRIP® in improving mammographic image quality and minimizing repeated breast positioning compared to standard practice without MammoGRIP®.

Interventions

  • Device MammoGRIP
    MammoGRIP® is an FDA-cleared, single-use, topical foam adhesive solution designed to improve technologist grip during breast positioning for mammography. In this study, MammoGRIP® will be used in accordance with the manufacturer's instructions and applied immediately before positioning each breast for imaging.

Primary outcome measures

  • Image quality [Time frame: Images from the current scan will be compared to the images from a historical scan (1 year prior)]
  • Image Quality [Time frame: Images from the current scan will be compared to the images from a historical scan (1 year prior)]
  • Image quality [Time frame: Images from the current scan will be compared to the images from a historical scan (1 year prior)]
  • Image Quality [Time frame: Images from the current scan will be compared to the images from a historical scan (1 year prior)]
  • Image Quality [Time frame: Images from the current scan will be compared to the images from a historical scan (1 year prior)]

Eligibility criteria

Inclusion criteria

  • Women aged 40-75 years undergoing routine screening or diagnostic mammography
  • Ability to provide informed consent
  • Prior mammogram results are available for the patient in Epic

Exclusion criteria

  • History of bilateral mastectomy
  • Active skin condition or open wounds on the breast or chest
  • Known allergy to components of MammoGRIP®

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • Englewood Hospital — Englewood

Identifiers

NCT: NCT07388940 · E-25-145

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗