MammographyMammoGRIPNCT07388940
Pilot Study of MammoGRIP for Breast Positioning, Image Quality, and Patient Comfort in Mammography
A study testing MammoGRIP in people with Mammography, run by Englewood Hospital and Medical Center at 1 site in United States.
Trial summary
To evaluate the effectiveness of MammoGRIP® in improving mammographic image quality and minimizing repeated breast positioning compared to standard practice without MammoGRIP®. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Mammography
- What is being tested?
- MammoGRIP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of bilateral mastectomy
- Active skin condition or open wounds on the breast or chest
- Known allergy to components of MammoGRIP®
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Englewood Hospital
Englewood, New Jersey, 07647
Dara Herman, 201-894-3944, dara.herman@ehmchealth.org
About this study
To evaluate the effectiveness of MammoGRIP® in improving mammographic image quality and minimizing repeated breast positioning compared to standard practice without MammoGRIP®.
- Conditions
- Mammography
- Being tested
- MammoGRIP
- Keywords
- Mammogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MammoGRIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality
- Pectoralis muscle visualization in MLO and or CC views
Measured: Images from the current scan will be compared to the images from a historical scan (1 year prior)
Image Quality
Nipple in profile
Measured: 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
Measured: Images from the current scan will be compared to the images from a historical scan (1 year prior)
Image Quality
Lack of skin folds
Measured: 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)
Measured: Images from the current scan will be compared to the images from a historical scan (1 year prior)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MammographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Englewood Hospital and Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388940
- Sponsor's protocol ID
- E-25-145
- Acronym
- MammoGRIP
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of MammoGRIP for Breast Positioning, Image Quality, and Patient Comfort in Mammography
- ClinicalTrials.gov ID
- NCT07388940
- Acronym / sponsor ID
- MammoGRIP / E-25-145
- Conditions
- Mammography
- Keywords
- Mammogram
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Englewood Hospital and Medical CenterUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effectiveness of MammoGRIP® in improving mammographic image quality and minimizing repeated breast positioning compared to standard practice without MammoGRIP®.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MammoGRIP | Experimental | Device: MammoGRIPMammoGRIP® 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- History of bilateral mastectomy
- Active skin condition or open wounds on the breast or chest
- Known allergy to components of MammoGRIP®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MammoGRIPMammoGRIP® 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 |
Primary outcome
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
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
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
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MammoGRIP in people with Mammography, run by Englewood Hospital and Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dara Herman (201-894-3944, dara.herman@ehmchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality (time frame: Images from the current scan will be compared to the images from a historical scan (1 year prior)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.