Evaluation of the Nella Women's Care Line

Ceek Enterprises

Status: Completed

Conditions: GYN Disorders

Treatments: Device: Group 2: Nella NuSpec; Device: Group 1: Nella VuSleeve; Device: Group 4: Nella Insert; Device: Group 3: NellaSpec

Study type: Interventional

Funder types: Industry

Identifiers

NCT03123367

CLP-0001

Details and patient eligibility

About

Evaluation of the Nella Women's Care Line

Full 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.

Enrollment: 154 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 4 patient groups

Group 1: Nella VuSleeve

Active Comparator group

Description:

Sleeve

Treatment:

Device: Group 1: Nella VuSleeve

Group 2: Nella NuSpec

Active Comparator group

Description:

Speculum

Treatment:

Device: Group 2: Nella NuSpec

Group 3: NellaSpec

Active Comparator group

Description:

Speculum

Treatment:

Device: Group 3: NellaSpec

Group 4: Nella Insert

Active Comparator group

Description:

Sleeve

Treatment:

Device: Group 4: Nella Insert