Evaluation of the Nella Women's Care Line | NCT03123367

Studies
Evaluation of the Nella Women's Care Line

NCT03123367

Sponsor

Ceek Enterprises

Status

Completed

Last Update Posted

Mar 16, 2018Actual

Enrollment

154Actual

Phase

Not Applicable

Conditions

GYN Disorders

Interventions

Group 1: Nella VuSleeve
Group 2: Nella NuSpec
Group 3: NellaSpec
Group 4: Nella Insert

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 6, 2017Actual

Primary Completion Date

Jun 27, 2017Actual

Completion Date

Jun 27, 2017Actual

First Submitted Date

Mar 5, 2017

First Submission Date that Met QC Criteria

Apr 20, 2017

First Posted Date

Apr 21, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2018

Last Update Posted Date

Mar 16, 2018Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

154Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1: Nella VuSleeve	Active Comparator	Sleeve	Device: Group 1: Nella VuSleeve
Group 2: Nella NuSpec	Active Comparator	Speculum	Device: Group 2: Nella NuSpec
Group 3: NellaSpec	Active Comparator	Speculum	Device: Group 3: NellaSpec
Group 4: Nella Insert	Active Comparator	Sleeve	Device: Group 4: Nella Insert

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Group 1: Nella VuSleeve	Device	Sleeve	Group 1: Nella VuSleeve
Group 2: Nella NuSpec

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

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases