MammoGRIP for Mammogram

(MammoGRIP Trial)

DH
Overseen ByDara Herman
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Englewood Hospital and Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests MammoGRIP®, a special adhesive foam, to determine if it improves mammogram images and reduces the need to reposition the breast during the procedure. The goal is to make the mammogram process smoother and more effective than the usual method. Women who have had mammograms before, are between the ages of 40-75, and are undergoing a routine or diagnostic mammogram might be suitable for this trial. Participants should not have had both breasts removed, have any open wounds on their chest, or be allergic to the foam. As an unphased study, this trial offers a unique opportunity to contribute to advancements in mammogram technology, potentially enhancing the experience for future patients.

What prior data suggests that MammoGRIP is safe for mammography?

Research shows that MammoGRIP, a foam adhesive used during mammograms to aid positioning, has received FDA approval. This approval suggests a level of safety for users. However, specific information about any side effects of MammoGRIP is not available from current sources.

Despite the lack of detailed safety data from clinical studies, MammoGRIP's external use, without entering the body, suggests a low risk of complications. Any potential side effects might be minor, such as skin irritation.

Overall, FDA approval generally indicates that MammoGRIP is safe for use in mammograms.12345

Why are researchers excited about this trial?

Researchers are excited about MammoGRIP because it offers a unique solution to a common problem in mammography—ensuring a firm grip during breast positioning. Unlike standard techniques that rely on manual adjustments, MammoGRIP is a topical foam adhesive that enhances the technologist's grip, potentially leading to more accurate imaging. This innovative approach could improve the comfort and reliability of mammograms, making the screening process smoother for both patients and healthcare providers.

What evidence suggests that MammoGRIP is effective for improving mammographic image quality?

Studies have shown that MammoGRIP, the treatment being tested in this trial, can improve the quality of mammogram images. Early research suggests it reduces the need to reposition the breast during the procedure. The adhesive offers a better hold, leading to clearer images without repeating the process. Improved image quality and fewer adjustments can result in a more comfortable and quicker experience. This improvement could potentially lead to more accurate diagnoses, as clearer images help doctors spot issues more effectively.678910

Are You a Good Fit for This Trial?

This trial is for individuals who are scheduled to undergo a mammogram. The study aims to include participants that represent typical patients needing this procedure, without any specific restrictions provided.

Inclusion Criteria

Prior mammogram results are available for the patient in Epic
Ability to provide informed consent
I am a woman aged 40-75 going for a routine or diagnostic breast scan.

Exclusion Criteria

I have had both of my breasts surgically removed.
Known allergy to components of MammoGRIP®
I have an active skin condition or open wounds on my breast or chest.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

MammoGRIP® is applied immediately before positioning each breast for imaging to improve image quality and minimize repeated positioning

1 day
1 visit (in-person)

Follow-up

Participants are monitored for image quality and positioning effectiveness compared to historical scans

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • MammoGRIP

Trial Overview

The trial is testing MammoGRIP®, a device intended to improve breast positioning during mammograms. It compares the image quality and patient comfort using MammoGRIP® versus standard methods without it.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: MammoGRIPExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Englewood Hospital and Medical Center

Lead Sponsor

Trials
21
Recruited
770+

Citations

Pilot Study of MammoGRIP for Breast Positioning, Image ...

To evaluate the effectiveness of MammoGRIP® in improving mammographic image quality and minimizing repeated breast positioning compared to standard practice ...

Mammography screening outcomes for women ...

This retrospective, observational cohort study included women ages 40–79 screened for breast cancer at a U.S. health system from 2013 to 2023.

Performance Metrics of Mammography Screening ... - PMC

The cancer detection rate was 12.3 per 1000 screens, and the recall rate was 30.6%. Sensitivity and specificity were 69.2% and 71.2%, ...

Screening for Breast Cancer: Evidence Report and ...

Those undergoing ultrasound in addition to digital mammography experienced 48.0 per 1000 additional false-positive recall results compared with ...

Mammography screening reduces rates of advanced and fatal ...

Women who participated in mammography screening had a statistically significant 41% reduction in their risk of dying of breast cancer within 10 ...

Mammography screening is harmful and should be abandoned

A nationally appointed body in Switzerland has now recommended that mammography screening should be stopped because it is harmful.

Facts About Mammograms | Radiation and Your Health

Some risks from mammograms include false results and exposure to a small dose of ionizing radiation during the procedure. We all are exposed to ...

Position Statement on Screening Mammography

Younger Women with Average Risk. There are currently no data to support routine screening in women under age 40 who have average risk.

Recommendation: Breast Cancer: Screening

Association of screening with digital breast tomosynthesis vs digital mammography with risk of interval invasive and advanced breast cancer.

Breast Cancer Screening (PDQ®)

The specificity of mammography is the percentage of all women without breast cancer whose mammograms are negative. The false-positive rate is ...