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

NCT ID: NCT05445115

Last Updated: 2022-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-14

Study Completion Date

2023-04-30

Brief Summary

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

Detailed Description

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Conditions

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Dyspareunia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Treatment arm and sham arm
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Subjects are blinded as to which arm they are participating in

Study Groups

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Treatment

Actual treatment device

Group Type EXPERIMENTAL

Mollie device

Intervention Type DEVICE

medical device

Sham

Sham/placebo device

Group Type SHAM_COMPARATOR

Mollie device

Intervention Type DEVICE

medical device

Interventions

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Mollie device

medical device

Intervention Type DEVICE

Other Intervention Names

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Sham

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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JSP Innovations

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vero Clinics

Decatur, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Leigh Ann Grossman

Role: CONTACT

217-615-1144

Facility Contacts

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Leigh Ann Grossman

Role: primary

217-615-1144

Other Identifiers

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CIP-01

Identifier Type: -

Identifier Source: org_study_id

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