Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT03123367
Eligibility Criteria:
General inclusion criteria (applies to all study groups):
* Subject is female
* Subject is 18 - 65 years of age, inclusive, at the time of consent
* Subject is undergoing a gynecological examination (as defined above) as part of their regular clinical care
* Subject has undergone one or more prior gynecological exams
* Subject is willing and able to provide written informed consent
* Subject is able and willing to perform the functions required by the study protocol
General exclusion criteria (applies to all study groups):
* Subject has undergone hysterectomy
* Subject has a known history of allergies to latex or plastics
* Subject is pregnant
* Subject is post-partum (≤ 12 weeks)
* Subject has had an induced or spontaneous abortion in the prior 12 weeks
* Subject has an active gynecologic complaint that, in the opinion of the clinician, would confound study results
* Subject has dyspareunia
* Subject has a known history of vulvodynia such as vulvular vestibular syndrome
* Subject has a known history of vaginismus
* Subject has a planned surgical procedure along with the gynecological exam
* Subject is under incarceration
* Subject is unable to provide written informed consent
Device specific inclusion criteria:
In addition to the general inclusion, the subject must meet all device specific criteria associated with their assignment group. Below are device-specific criteria. There is no device-specific exclusion criterion.
Nella VuSleeve (Group 1) inclusion:
• Subject has a BMI ≥ 30 and/or 3 or more vaginal births
NellaSpec (Group 2), Nella NuSpec (Group 3), and Nella Insert (Group 4) inclusion:
• Subject has a BMI \< 35
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03123367
Study Brief:
Protocol Section:
NCT03123367