Trials / Completed
CompletedNCT03123367
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)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 154 (actual)
- Sponsor
- Ceek Enterprises · Industry
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Group 1: Nella VuSleeve | Sleeve |
| DEVICE | Group 2: Nella NuSpec | Speculum |
| DEVICE | Group 3: NellaSpec | Speculum |
| DEVICE | Group 4: Nella Insert | Sleeve |
Timeline
- Start date
- 2017-03-06
- Primary completion
- 2017-06-27
- Completion
- 2017-06-27
- First posted
- 2017-04-21
- Last updated
- 2018-03-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03123367. Inclusion in this directory is not an endorsement.