Pro00019086 - Ultra Circumference Reduction

Circumference Reduction of Abdomen Clinical Trial

Official title:

A Multi-Center Pilot Study to Assess the Safety and Efficacy of the vShape Ultra UltraSpeed Handpiece for Abdomen Circumference Reduction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03115944
• Other study ID #: AlmaLasersInc
• Status: Active, not recruiting
• Phase: N/A
• First received: October 13, 2016
• Last updated: November 28, 2017
• Start date: October 2016
• Est. completion date: November 2017

Study information

• Verified date: April 2017
• Source: Alma Lasers Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Multi-Center Pilot Study to Assess the Safety and Efficacy of the VShape Ultra UltraSpeed Handpiece for Abdomen Circumference Reduction

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Circumference Reduction of Abdomen

Intervention

Device:
• Alma vShape Ultra
UltraSpeed ultrasound treatment, a series of four treatments

Locations

Country	Name	City	State
United States	Maryland Plastic Surgery	Glen Burnie	Maryland
United States	AboutSkin Dermatology	Greenwood Village	Colorado
United States	Dr. Brian S. Biesman	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Alma Lasers Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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