Evaluation of the Nella Women's Care Line

March 14, 2018 updated by: Ceek Enterprises

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

Evaluation of the Nella Women's Care Line

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97209
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: Nella VuSleeve
Sleeve
Device: Group 1: Nella VuSleeve
Sleeve
Active Comparator: Group 2: Nella NuSpec
Speculum
Device: Group 2: Nella NuSpec
Speculum
Active Comparator: Group 3: NellaSpec
Speculum
Device: Group 3: NellaSpec
Speculum
Active Comparator: Group 4: Nella Insert
Sleeve
Device: Group 4: Nella Insert
Sleeve

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ceek Enterprises

Investigators

  • Study Director: Ceek Clinical Research, Ceek Enterprises

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2017

Primary Completion (Actual)

June 27, 2017

Study Completion (Actual)

June 27, 2017

Study Registration Dates

First Submitted

March 5, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (Actual)

April 21, 2017

Study Record Updates

Last Update Posted (Actual)

March 16, 2018

Last Update Submitted That Met QC Criteria

March 14, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • CLP-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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