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NCT Number: NCT07388940

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

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

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Key information

Conditions

Mammography

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

MammoGRIP

Device

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 outcomes

  1. Image quality

    Time frame: Images from the current scan will be compared to the images from a historical scan (1 year prior)

    • Pectoralis muscle visualization in MLO and or CC views

  2. Image Quality

    Time frame: Images from the current scan will be compared to the images from a historical scan (1 year prior)

    Nipple in profile

  3. Image quality

    Time frame: Images from the current scan will be compared to the images from a historical scan (1 year prior)

    Visualization of the inframammary fold

  4. Image Quality

    Time frame: Images from the current scan will be compared to the images from a historical scan (1 year prior)

    Lack of skin folds

  5. Image Quality

    Time frame: Images from the current scan will be compared to the images from a historical scan (1 year prior)

    Distance from the chest wall to the nipple on MLO and CC views (less than 1cm)

Study contacts

Contact information is provided by the study sponsor or research team.

Dara Herman

CONTACT

[email protected]

201-894-3944

Sponsors and collaborators

Lead sponsor

Englewood Hospital and Medical Center

Other

Registry information

Acronym: MammoGRIP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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