A Multicenter, Two-Arm, Randomized, Controlled Study to Evaluate the Effectiveness of the UltraShape® Contour I VER 3.1 System for Non-Invasive Reduction in Abdominal Circumference

Study ID
STU 062012-046

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern Ambulatory Services

Contact
Xiaohong Xu
214-648-0388
xiaohong.xu@utsouthwestern.edu

Principal Investigator
Jeffrey Kenkel

Summary

This is a two-arm controlled study that will include subjects between the age of 18 and 65 who meet all inclusion criteria and have no exclusion criteria.
In this study, the abdominal circumference of each subject is measured at enrollment. Each subject is then randomized into one of two groups and measurements are taken in both groups every two weeks until the end of the treatment phase of Group 1. Subjects in Group 2 initially undergo treatment for six weeks while Group 1 subjects receive no treatment for the initial six weeks, while being assessed in parallel to Group 2. After the first six weeks, Group 2 ends its treatment phase while Group 1 begins treatment for six weeks. During Group 1 and amp;apos;s treatment phase both groups and amp;apos; abdomen circumference continues to be measured every 2 weeks. At the end of Group 1 and #146;s treatment phase both groups continue to be measured for an additional 3 months (12 weeks). During this period of 3 months (12 weeks) all subjects will be measured every 4 weeks.
Duration of each treatment session is approximately 60 minutes and performed on a bi-weekly basis.
Abdominal circumference is measured using a standardized circumference measuring technique and subjects are instructed to fast for 3 hours before coming to the clinic. Additionally, subjects and amp;apos; weight is recorded at each visit.

Participant Eligibility

A subject is eligible to participate in the study if he/she meets all the following inclusion criteria:
1. Female or male subjects,≥18 and ≤ 65 years of age at the time of enrollment
2. Abdominal fat thickness of at least 1.5 cm prior to initial treatment (measurement by caliper)
3. For women of child-bearing potential: negative pregnancy test 24 hours prior to enrollment (measured in urine)
4. General good health confirmed by medical history and skin examination of the treated area
5. Written informed consent to participate in the study
6. Ability to comply with the requirements of the study
7. BMI ≤ 30

Intra-procedural Inclusion criteria (prior to starting the treatment phase):
Subjects are eligible to continue the study and participate in the treatment phase if she meets all of the following intra-procedural inclusion criteria:
8. For women of child-bearing potential: negative pregnancy test 24 hours prior to first treatment (measured in urine)
9. Abdominal fat thickness of at least 1.5 cm prior to initial treatment (measurement by caliper)