Evaluation of the Nella Women's Care Line

Study Overview
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Brief Summary
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Evaluation of the Nella Women's Care Line

Detailed Description
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The Nella Women's Care Line is being studied in women undergoing a gynecological exam and other gynecological procedures that require visibility and access to the cervix.

Official Title
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An Evaluation of the Safety and TechnIcal Feasibility Of the NelLa Women's Care Line for Female Gynecological ExaminaTions and Procedures (VIOLET)

Conditions
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GYN Disorders

Intervention / Treatment
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* Device: Group 1: Nella VuSleeve
* Device: Group 2: Nella NuSpec
* Device: Group 3: NellaSpec
* Device: Group 4: Nella Insert


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: Nella VuSleeve<br>Sleeve | Device: Group 1: Nella VuSleeve<br>* Sleeve<br>|
| Active Comparator: Group 2: Nella NuSpec<br>Speculum | Device: Group 2: Nella NuSpec<br>* Speculum<br>|
| Active Comparator: Group 3: NellaSpec<br>Speculum | Device: Group 3: NellaSpec<br>* Speculum<br>|
| Active Comparator: Group 4: Nella Insert<br>Sleeve | Device: Group 4: Nella Insert<br>* Sleeve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Feasibility | Cervical visualization and access | Day of Exam or Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Number of Adverse Events (AEs) | Day of Exam or Procedure |