Circumference Reduction of AbdomenNCT03115944
Pro00019086 - Ultra Circumference Reduction
A study testing Alma vShape Ultra in people with Circumference Reduction of Abdomen, run by Alma Lasers Inc. at 3 sites in United States.
Trial summary
A Multi-Center Pilot Study to Assess the Safety and Efficacy of the VShape Ultra UltraSpeed Handpiece for Abdomen Circumference Reduction Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Circumference Reduction of Abdomen
- What is being tested?
- Alma vShape Ultra
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2016to Nov 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent to participate in the study.
- Female and male subjects, between 18 and 45 years of age at the time of enrollment.
- Fitzpatrick Skin Type I to VI.
- Fat thickness of at least 1.5 cm in the treated area (measured by calibrated caliper).
- BMI interval: BMI between 20 to 30 (normal to overweight, but not obese).
- If female, not pregnant or lactating, must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence).
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- In addition, negative urine pregnancy test as tested before each treatment and at the last follow-up visit for women with childbearing potential (e.g., not menopausal).
- General good health confirmed by medical history and skin examination of the treated area.
- Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
- Willingness to refrain from a change in diet / exercise / medication regimen for the entire course of the study.
- Willing to have photographs and images taken of the treated areas to be used, de-identified in evaluations, publications and presentations.
Who cannot join
- History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker / defibrillator, abnormal aortic aneurism.
- Known hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease.
- Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Having a permanent implant in the treated area, such as metal plates or an injected chemical substance such as silicone.
- Having undergone any other surgery in the treated areas within 12 months of treatment or during the study, including liposuction.
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- Previous body contouring procedures in the treatment area within 12 months.
- History of skin disease in the treatment area; known tendency to form keloids or poor wound healing.
- Suffering from significant skin conditions in the treatment areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during treatment course.
- Skin lesions in the treatment area other than simple nevi on physical examination (e.g., atypical nevus, tattoo, abrasions), including depressed scars in the treatment area.
- Very poor skin quality (i.e., severe laxity).
- Abnormal wall diastasis or hernia on physical examination.
- Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months.
- Obesity (BMI above 30)
- Childbirth within the last 12 months or breastfeeding women.
- Any acute or chronic condition which, in the opinion of the Investigator may exclude the candidate / patient from entry into the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Maryland Plastic Surgery
Glen Burnie, Maryland, 21061
AboutSkin Dermatology
Greenwood Village, Colorado, 80111
Dr. Brian S. Biesman
Nashville, Tennessee, 37203
About this study
Official title: A Multi-Center Pilot Study to Assess the Safety and Efficacy of the vShape Ultra UltraSpeed Handpiece for Abdomen Circumference Reduction
A Multi-Center Pilot Study to Assess the Safety and Efficacy of the VShape Ultra UltraSpeed Handpiece for Abdomen Circumference Reduction
- Conditions
- Circumference Reduction of Abdomen
- Being tested
- Alma vShape Ultra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alma vShape UltraDevice
Also called UltraSpeed
UltraSpeed ultrasound treatment, a series of four treatments
| Study group | Role | What they receive |
|---|---|---|
| UltraSpeed Treatment | Experimental | UltraSpeed ultrasound treatments Receives: Device: Alma vShape Ultra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Circumference Reduction as Measured by Skin Fold and Photography
Skin fold measure utilizes caliper and photography utilizes Galaxy medical camera with extrapolation of measuring dot. Last measurement taken 14 days after final treatment.
Measured: 4 Treatments over 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study startOct 2016
- Primary completionNov 2017
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circumference Reduction of AbdomenStudies 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
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alma Lasers Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115944
- Sponsor's protocol ID
- AlmaLasersInc
- Status last verified
- Apr 2017
- First submitted
- 13 Oct 2016
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Pilot Study to Assess the Safety and Efficacy of the vShape Ultra UltraSpeed Handpiece for Abdomen Circumference Reduction
- ClinicalTrials.gov ID
- NCT03115944
- Acronym / sponsor ID
- AlmaLasersInc
- Conditions
- Circumference Reduction of Abdomen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Alma Lasers Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (estimated)
- First posted
- 14 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.
A Multi-Center Pilot Study to Assess the Safety and Efficacy of the VShape Ultra UltraSpeed Handpiece for Abdomen Circumference Reduction
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UltraSpeed Treatment | Experimental | Device: Alma vShape UltraUltraSpeed ultrasound treatments |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Signed informed consent to participate in the study.
- Female and male subjects, between 18 and 45 years of age at the time of enrollment.
- Fitzpatrick Skin Type I to VI.
- Fat thickness of at least 1.5 cm in the treated area (measured by calibrated caliper).
- BMI interval: BMI between 20 to 30 (normal to overweight, but not obese).
Key exclusion criteria (16 listed)
- History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker / defibrillator, abnormal aortic aneurism.
- Known hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease.
- Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Having a permanent implant in the treated area, such as metal plates or an injected chemical substance such as silicone.
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 |
|---|---|---|
| Alma vShape UltraAlso: UltraSpeedUltraSpeed ultrasound treatment, a series of four treatments | Device | UltraSpeed Treatment |
Primary outcome
Average Circumference Reduction as Measured by Skin Fold and Photography
Time frame: 4 Treatments over 4 Weeks
Skin fold measure utilizes caliper and photography utilizes Galaxy medical camera with extrapolation of measuring dot. Last measurement taken 14 days after final treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Individual participant dataSharing planned: Undecided
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alma vShape Ultra in people with Circumference Reduction of Abdomen, run by Alma Lasers Inc. at 3 sites 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 11 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 30 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 3 sites 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?
Results are not available in the source record.
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?
Average Circumference Reduction as Measured by Skin Fold and Photography (time frame: 4 Treatments over 4 Weeks). 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 30 Nov 2017.