GYN Disorders
Conditions
Brief summary
Evaluation of the Nella Women's Care Line
Detailed description
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.
Interventions
DEVICEGroup 1: Nella VuSleeve
Sleeve
DEVICEGroup 2: Nella NuSpec
Speculum
DEVICEGroup 3: NellaSpec
Speculum
DEVICEGroup 4: Nella Insert
Sleeve
Sponsors
Ceek Enterprises
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Feasibility | Day of Exam or Procedure | Cervical visualization and access |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | Day of Exam or Procedure | Number of Adverse Events (AEs) |
Countries
United States
Outcome results
None listed