Evaluation of the Nella Women's Care Line
An Evaluation of the Safety and TechnIcal Feasibility Of the NelLa Women's Care Line for Female Gynecological ExaminaTions and Procedures (VIOLET)
1 other identifier
interventional
154
1 country
1
Brief Summary
Evaluation of the Nella Women's Care Line
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2017
CompletedStudy Start
First participant enrolled
March 6, 2017
CompletedFirst Posted
Study publicly available on registry
April 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2017
CompletedMarch 16, 2018
March 1, 2018
4 months
March 5, 2017
March 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Technical Feasibility
Cervical visualization and access
Day of Exam or Procedure
Secondary Outcomes (1)
Safety
Day of Exam or Procedure
Study Arms (4)
Group 1: Nella VuSleeve
ACTIVE COMPARATORSleeve
Group 2: Nella NuSpec
ACTIVE COMPARATORSpeculum
Group 3: NellaSpec
ACTIVE COMPARATORSpeculum
Group 4: Nella Insert
ACTIVE COMPARATORSleeve
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Subject has a BMI ≥ 30 and/or 3 or more vaginal births
- Subject has a BMI \< 35
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ceek Enterpriseslead
Study Sites (1)
Research Site
Portland, Oregon, 97209, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ceek Clinical Research
Ceek Enterprises
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2017
First Posted
April 21, 2017
Study Start
March 6, 2017
Primary Completion
June 27, 2017
Study Completion
June 27, 2017
Last Updated
March 16, 2018
Record last verified: 2018-03