GYN DisordersNCT03123367
Evaluation of the Nella Women's Care Line
A study testing Group 1: Nella VuSleeve, Group 2: Nella NuSpec and Group 3: NellaSpec in people with GYN Disorders, run by Ceek Enterprises at 1 site in United States.
Trial summary
Evaluation of the Nella Women's Care Line Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- GYN Disorders
- What is being tested?
- Group 1: Nella VuSleeve, Group 2: Nella NuSpec and Group 3: NellaSpec
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2017to 27 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- GYN Disorders
- Being tested
- Group 1: Nella VuSleeve, Group 2: Nella NuSpec, Group 3: NellaSpec, Group 4: Nella Insert
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: Nella VuSleeveDevice
Sleeve
Group 2: Nella NuSpecDevice
Speculum
Group 3: NellaSpecDevice
Speculum
Group 4: Nella InsertDevice
Sleeve
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Nella VuSleeve | Active comparator | Sleeve Receives: Device: Group 1: Nella VuSleeve |
| Group 2: Nella NuSpec | Active comparator | Speculum Receives: Device: Group 2: Nella NuSpec |
| Group 3: NellaSpec | Active comparator | Speculum Receives: Device: Group 3: NellaSpec |
| Group 4: Nella Insert | Active comparator | Sleeve Receives: Device: Group 4: Nella Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Feasibility
Cervical visualization and access
Measured: Day of Exam or Procedure
Secondary outcomes (1)
Safety
Number of Adverse Events (AEs)
Measured: Day of Exam or Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start6 Mar 2017
- Primary completion27 Jun 2017
- Study completion27 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GYN DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ceek Enterprises
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ceek Clinical Research, Study director, Ceek Enterprises
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123367
- Sponsor's protocol ID
- CLP-0001
- Status last verified
- Mar 2018
- First submitted
- 5 Mar 2017
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Safety and TechnIcal Feasibility Of the NelLa Women's Care Line for Female Gynecological ExaminaTions and Procedures (VIOLET)
- ClinicalTrials.gov ID
- NCT03123367
- Acronym / sponsor ID
- CLP-0001
- Conditions
- GYN Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Ceek EnterprisesIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 27 Jun 2017 (actual)
- Study completion
- 27 Jun 2017 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Nella VuSleeve | Active comparator | Device: Group 1: Nella VuSleeveSleeve |
| Group 2: Nella NuSpec | Active comparator | Device: Group 2: Nella NuSpecSpeculum |
| Group 3: NellaSpec | Active comparator | Device: Group 3: NellaSpecSpeculum |
| Group 4: Nella Insert | Active comparator | Device: Group 4: Nella InsertSleeve |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1: Nella VuSleeveSleeve | Device | Group 1: Nella VuSleeve |
| Group 2: Nella NuSpecSpeculum | Device | Group 2: Nella NuSpec |
| Group 3: NellaSpecSpeculum | Device | Group 3: NellaSpec |
| Group 4: Nella InsertSleeve | Device | Group 4: Nella Insert |
Primary outcome
Technical Feasibility
Time frame: Day of Exam or Procedure
Cervical visualization and access
1 secondary outcome
Safety
Time frame: Day of Exam or Procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ceek Clinical Research study director
Ceek Enterprises
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1: Nella VuSleeve, Group 2: Nella NuSpec and Group 3: NellaSpec in people with GYN Disorders, run by Ceek Enterprises at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Feasibility (time frame: Day of Exam or Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2018.