NCT07388940

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Feb 2026Feb 2027

First Submitted

Initial submission to the registry

January 21, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 21, 2026

Last Update Submit

January 28, 2026

Conditions

Keywords

Mammogram

Outcome Measures

Primary Outcomes (5)

  • Image quality

    \- 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

    Nipple in profile

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

  • Image quality

    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

    Lack of skin folds

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

  • Image Quality

    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)

Study Arms (1)

MammoGRIP

EXPERIMENTAL

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

Interventions

MammoGRIPDEVICE

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.

MammoGRIP

Eligibility Criteria

Age40 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Englewood Hospital

Englewood, New Jersey, 07647, United States

Location

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

February 5, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

February 5, 2026

Record last verified: 2026-01

Locations