Evaluation of the Nella Women's Care Line

GYN Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03123367
• Other study ID #: CLP-0001
• Status: Completed
• Phase: N/A
• First received: March 5, 2017
• Last updated: March 14, 2018
• Start date: March 6, 2017
• Est. completion date: June 27, 2017

Study information

• Verified date: March 2018
• Source: Ceek Enterprises
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of the Nella Women's Care Line

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: June 27, 2017
• Est. primary completion date: June 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• GYN Disorders

Intervention

Device:
• Group 1: Nella VuSleeve
Sleeve
• Group 2: Nella NuSpec
Speculum
• Group 3: NellaSpec
Speculum
• Group 4: Nella Insert
Sleeve

Locations

Country	Name	City	State
United States	Research Site	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Ceek Enterprises

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical Feasibility	Cervical visualization and access	Day of Exam or Procedure
Secondary	Safety	Number of Adverse Events (AEs)	Day of Exam or Procedure