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The Mollie Study, a Study to Evaluate the Safety and Efficacy of the Mollie Medical Device

Sponsor
JSP Innovations (Other)
Overall Status
Recruiting
CT.gov ID
NCT05445115
Collaborator
(none)
111
Enrollment
1
Location
2
Arms
19.5
Anticipated Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study to evaluate the use of a medical device in relieving collision dyspareunia

Condition or Disease Intervention/Treatment Phase
  • Device: Mollie device
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
111 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Treatment arm and sham armTreatment arm and sham arm
Masking:
Single (Participant)
Masking Description:
Subjects are blinded as to which arm they are participating in
Primary Purpose:
Treatment
Official Title:
DAT: Dyspareunia Alleviation Trial
Actual Study Start Date :
Sep 14, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

Actual treatment device

Device: Mollie device
medical device
Other Names:
  • Sham

    		•
    Sham Comparator: Sham

    Sham/placebo device

    Device: Mollie device
    medical device
    Other Names:
  • Sham

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Dyspareunia Alleviation [12 weeks]

      The Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v.4.0, Change from Baseline in Pain Scores on the Visual Analog Scale at 13 Weeks

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes

    Inclusion Criteria: Females 18 years of age and older with a diagnosis of collision dyspareunia -

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vero Clinics Decatur Illinois United States 62526

    Sponsors and Collaborators

    • JSP Innovations

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    JSP Innovations
    ClinicalTrials.gov Identifier:
    NCT05445115
    Other Study ID Numbers:
    • CIP-01
    First Posted:
    Jul 6, 2022
    Last Update Posted:
    Jul 6, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Dyspareunia

    Study Results

    No Results Posted as of Jul 6, 2022