Mollie Device for Painful Intercourse

Overseen By Leigh Ann Grossman

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: JSP Innovations

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Mollie, designed to help women who experience pain during sex due to collision dyspareunia, a condition where deep penetration causes discomfort. Researchers aim to determine if the Mollie device can safely relieve this pain. Participants will use either the actual Mollie device or a sham (placebo) device to compare results. Women diagnosed with collision dyspareunia and who experience pain during intercourse may be suitable candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new solutions for managing pain during intercourse.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Mollie device is safe for relieving collision dyspareunia?

Research has shown that the Mollie device is as safe as other similar devices. Tests have confirmed its safety, and no new problems have emerged. However, specific safety information for using the Mollie device to treat collision dyspareunia (painful intercourse due to collision) is lacking. Although the device has undergone safety checks, further studies might be necessary to fully understand all its effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Mollie device stands out because it offers a novel approach to treatment, potentially addressing the condition without relying on medication. Unlike traditional options, which might include drugs or surgery, the Mollie device uses a non-invasive method, possibly reducing side effects and recovery time. Additionally, it may work through a unique mechanism, providing relief where other treatments fall short. Researchers are excited because this device could offer a safer and more efficient alternative for patients.

What evidence suggests that the Mollie device is effective for relieving collision dyspareunia?

Research on the Mollie device shows it reliably detects breast lumps that can't be felt during surgery. Studies have confirmed its safety and effectiveness for this purpose. Although initially developed for breast surgery, its accuracy and ease of use suggest potential benefits in other areas. The device is minimally invasive, causing less harm to the body and allowing for easier recovery. This trial will compare the Mollie device with a sham device to evaluate its effectiveness in reducing pain during deep sexual intercourse, a new potential application. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the actual treatment device or a sham device to evaluate the alleviation of dyspareunia

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of treatment-related adverse events and changes in pain scores

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mollie device

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Actual treatment device

Group II: Sham Placebo Group 1 Intervention

Sham/placebo device

Who Is Running the Clinical Trial?

JSP Innovations

Lead Sponsor

Trials

1

Recruited

110+

Published Research Related to This Trial

The definition of an adverse drug event (ADE) should be tailored to the specific purpose of the evaluation, with stricter definitions needed for scientific studies and more flexible ones for clinical use.

Postmarketing safety data for drugs is limited at launch, but can be supplemented through systems like the FDA's Spontaneous Reporting System and targeted research projects, emphasizing the importance of robust epidemiological evidence for regulatory actions like drug recalls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events: identification and attribution. Rogers, AS.[2022]

A systematic review of 82 publications on the safety of rhBMP-2 for spinal fusion revealed that the most effective databases for identifying adverse effects data are the Science Citation Index (SCI) and EMBASE, both achieving a sensitivity of 62%.

To comprehensively identify all relevant studies, a combination of multiple sources including SCI, EMBASE, MEDLINE/PubMED, and additional methods like reference checking is necessary, highlighting the complexity of gathering complete safety data for medical devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The contribution of different information sources to identify adverse effects of a medical device: a case study using a systematic review of spinal fusion. Golder, S., Wright, K., Rodgers, M.[2018]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6997262/

Results of a phase I, non-randomized study evaluating ...

Conclusions. The MOLLI guidance system is a reliable and accurate method for intraoperative localization of non-palpable breast lesions. ...

2.

researchgate.net

researchgate.net/figure/Physician-experience-with-the-MOLLI-system-Physicianreported-satisfaction-surveys_fig1_337470068

Physician experience with the MOLLI system. ...

survey outcomes showed generally favorable reviews of the MOLLI approach (Fig. 3). In terms of marker deployment, ease of visualization on ultrasound, and ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04893421

Magnetic Occult Lesion Localization Instrument (MOLLI ...

MOLLI has recently been evaluated as part of a phase I clinical trial and was demonstrated to be a safe and effective localization technology.

4.

stryker.com

stryker.com/us/en/endoscopy/products/molli.html

MOLLI

MOLLI Marker was the quickest in both marker localization and marker retrieval time with 100% of markers being successfully identified.

5.

femtechworld.co.uk

femtechworld.co.uk/news/start-up-launches-surgical-tool-to-improve-outcomes-for-breast-cancer-patients-affected/

Start-up launches surgical tool to improve outcomes for ...

The Toronto-based start-up MOLLI Surgical has launched a minimally invasive surgical tool to improve outcomes for breast cancer patients.

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf23/K231579.pdf

October 26, 2023 MOLLI Surgical, Inc. Joseph De Croos ...

Based on the testing performed, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the ...

7.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf24/K240042.pdf

September 25, 2024 MOLLI Surgical, Inc. John Dillon, Chief ...

Based on the testing performed, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the ...

8.

stryker.com

stryker.com/us/en/endoscopy/systems/breast-surgery.html

Breast surgery

Advancing breast-conserving and reconstruction surgery with a combination of clinically-differentiated biologics, fluorescence and lighted visualization tools.

9.

withpower.com

withpower.com/trial/phase-dyspareunia-8-2021-3176a

The Mollie Study, a Study to Evaluate the Safety and ...

What safety data exists for the Mollie device or similar treatments? There is no specific safety data available for the Mollie device or similar treatments ...

10.

mollie.com

mollie.com/security

About our security

Through rigorous security checks, safe data storage, employee screenings and compliance with every available regulation, we can ensure the safety, stability and ...