The Mollie Study, a Study to Evaluate the Safety and Efficacy of the Mollie Medical Device
LA
Overseen ByLeigh Ann Grossman
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: JSP Innovations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
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 safety data exists for the Mollie device or similar treatments?
What is the purpose of this trial?
This trial is testing a medical device designed to help people who experience pain during sex by reducing the pressure or impact that causes discomfort.
Eligibility Criteria
Timeline
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
Treatment Details
Interventions
- Mollie device
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Actual treatment device
Group II: ShamPlacebo Group1 Intervention
Sham/placebo device
Find a Clinic Near You
Who Is Running the Clinical Trial?
JSP Innovations
Lead Sponsor
Trials
1
Recruited
110+
Findings from Research
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]
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]
References
The contribution of different information sources to identify adverse effects of a medical device: a case study using a systematic review of spinal fusion. [2018]
Medical Devices: Classification and Analysis of Faults Leading to Harms. [2021]
Adverse Event Data for Years 2018 to 2020 for Diabetes Devices. [2022]
The impact of minor adverse event tracking on subject safety: a web-based system. [2009]
Adverse drug events: identification and attribution. [2022]
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