Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
154 participants
INTERVENTIONAL
2017-03-06
2017-06-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Group 1: Nella VuSleeve
Sleeve
Group 1: Nella VuSleeve
Sleeve
Group 2: Nella NuSpec
Speculum
Group 2: Nella NuSpec
Speculum
Group 3: NellaSpec
Speculum
Group 3: NellaSpec
Speculum
Group 4: Nella Insert
Sleeve
Group 4: Nella Insert
Sleeve
Interventions
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Group 1: Nella VuSleeve
Sleeve
Group 2: Nella NuSpec
Speculum
Group 3: NellaSpec
Speculum
Group 4: Nella Insert
Sleeve
Eligibility Criteria
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Inclusion Criteria
* 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
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
Exclusion Criteria
* 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
18 Years
65 Years
FEMALE
Yes
Sponsors
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Ceek Enterprises
INDUSTRY
Responsible Party
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Principal Investigators
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Ceek Clinical Research
Role: STUDY_DIRECTOR
Ceek Enterprises
Locations
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Research Site
Portland, Oregon, United States
Countries
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Other Identifiers
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CLP-0001
Identifier Type: -
Identifier Source: org_study_id
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