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

January 28, 2026 updated by: Englewood Hospital and Medical Center
To evaluate the effectiveness of MammoGRIP® in improving mammographic image quality and minimizing repeated breast positioning compared to standard practice without MammoGRIP®.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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®

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Nipple in profile
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)
Visualization of the inframammary fold
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)
Lack of skin folds
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)
Distance from the chest wall to the nipple on MLO and CC views (less than 1cm)
Images from the current scan will be compared to the images from a historical scan (1 year prior)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Englewood Hospital and Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E-25-145

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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