Pro00019086 - Ultra Circumference Reduction

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

Study Overview

• Status: Unknown
• Conditions: Circumference Reduction of Abdomen
• Intervention / Treatment: Device: Alma vShape Ultra

• Study Type: Interventional
• Enrollment (Anticipated): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • AboutSkin dermatology
  • Maryland
    • Glen Burnie, Maryland, United States, 21061
      • Maryland Plastic Surgery
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Dr. Brian S. Biesman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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).
• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UltraSpeed Treatment; UltraSpeed ultrasound treatments	Device: Alma vShape Ultra; UltraSpeed ultrasound treatment, a series of four treatments; Other Names: UltraSpeed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 Treatments over 4 Weeks

Collaborators and Investigators

• Sponsor: Alma Lasers Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): November 30, 2017
• Last Update Submitted That Met QC Criteria: November 28, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: AlmaLasersInc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED