AtrophyNCT02747641
Prospective, Open-Label, Single-Center, Non-Comparative Study to Assess the Use of Pixel CO2 Laser System (FemiLift) in the Treatment of Vulvovaginal Atrophy (VVA) in Postmenopausal Female Subjects
A study testing Pixel CO2 Laser System in people with Atrophy and Vaginal Atrophy, run by Alma Lasers Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the use of the Alma CO2 Pixel FemiLift™ in the treatment of VulvoVaginal Atrophy (VVA) in postmenopausal female subjects. The primary endpoint is to assess the change in the vaginal dryness by means of a Visual Analogic Scale (10 cm VAS) and/or Bachmann Index in VVA. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atrophy, Vaginal Atrophy, Genital Diseases, Female
- What is being tested?
- Pixel CO2 Laser System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Aug 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 35 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, non-smoking
- Woman, age 35 to 70 yrs, menopausal
- Provided written Informed Consent
- Exhibiting VVA and/or SUI symptoms (mild or moderate SUI, according to severity index developed by Sandvik.)
- Prolapse staged < II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system
- Normal PAP smear (up to 1 year prior to baseline)
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- Vaginal canal, introitus and vestibule free of injuries and bleeding
- Have not had procedures in the anatomical area through 6 months prior to treatment
- Understand and accept the obligation and is logistically able to present for all scheduled follow-up visits
Who cannot join
- Severe prolapse (POP>= grade 3)
- Use of photosensitive drugs
- Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. herpes candida).
- Any serious disease, or chronic condition, that could interfere with the study compliance
- Acute or actively present within the last 2 months HPV/HSV
- Undiagnosed vaginal bleeding
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- Urge or overflow incontinence
- Patients who are on antidepressants, or α-adrenergic and anticholinergic medications
- Patients with immune system diseases.
- Patients with allergic reaction to laser.
- Obese women (BMI >30)
- Patient unable to follow post-treatment instructions
- History of keloid formation
- Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment
- A history of thrombophlebitis
- A history of acute infections
- A history of heart failure
- Previously undergone reconstructive pelvic surgery
- Have used vaginal creams, moisturizers, lubricants or homeopathic preparations for at least 3 months
- Any medical condition that in the investigators opinion would interfere with the patients participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the use of the Alma CO2 Pixel FemiLift™ in the treatment of VulvoVaginal Atrophy (VVA) in postmenopausal female subjects. The primary endpoint is to assess the change in the vaginal dryness by means of a Visual Analogic Scale (10 cm VAS) and/or Bachmann Index in VVA. The clinical improvement will be assessed by patient filled Vulvovaginal Atrophy.
- Conditions
- Atrophy, Vaginal Atrophy, Genital Diseases, Female
- Being tested
- Pixel CO2 Laser System
- Medical subject headings
- Atrophy, Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pixel CO2 Laser SystemProcedure or surgery
Also called FemiLift
| Study group | Role | What they receive |
|---|---|---|
| treatment | Other | only one arm Receives: Procedure: Pixel CO2 Laser System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vulvovaginal Atrophy (VVA)
Utilizing Bachman Vaginal Health Index
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtrophyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alma Lasers Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747641
- Sponsor's protocol ID
- FLA 15-110
- Status last verified
- Oct 2016
- First submitted
- 12 Apr 2016
- Last updated
- 21 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-Label, Single-Center, Non-Comparative Study to Assess the Use of Pixel CO2 Laser System (FemiLift) in the Treatment of Vulvovaginal Atrophy (VVA) in Postmenopausal Female Subjects
- ClinicalTrials.gov ID
- NCT02747641
- Acronym / sponsor ID
- FLA 15-110
- Conditions
- Atrophy, Vaginal Atrophy, Genital Diseases, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Alma Lasers Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 22 Apr 2016 (estimated)
- 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.
The purpose of this study is to assess the use of the Alma CO2 Pixel FemiLift™ in the treatment of VulvoVaginal Atrophy (VVA) in postmenopausal female subjects. The primary endpoint is to assess the change in the vaginal dryness by means of a Visual Analogic Scale (10 cm VAS) and/or Bachmann Index in VVA. The clinical improvement will be assessed by patient filled Vulvovaginal Atrophy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Other | Procedure: Pixel CO2 Laser Systemonly one arm |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy, non-smoking
- Woman, age 35 to 70 yrs, menopausal
- Provided written Informed Consent
- Exhibiting VVA and/or SUI symptoms (mild or moderate SUI, according to severity index developed by Sandvik.)
- Prolapse staged < II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system
Key exclusion criteria (20 listed)
- Severe prolapse (POP>= grade 3)
- Use of photosensitive drugs
- Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. herpes candida).
- Any serious disease, or chronic condition, that could interfere with the study compliance
- Acute or actively present within the last 2 months HPV/HSV
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 |
|---|---|---|
| Pixel CO2 Laser SystemAlso: FemiLift | Procedure or surgery | treatment |
Primary outcome
Vulvovaginal Atrophy (VVA)
Time frame: 6 months
Utilizing Bachman Vaginal Health Index
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 21 Nov 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pixel CO2 Laser System in people with Atrophy and Vaginal Atrophy, run by Alma Lasers Inc. 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?
The sponsor lists 9 inclusion and 20 exclusion criteria. 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 21 Nov 2017. 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?
Vulvovaginal Atrophy (VVA) (time frame: 6 months). 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 21 Nov 2017.