Retrospective Study of Patient Surveys

Retrospective Study of Patient Surveys of MMS Experience

To collect data from Allergan Patient Surveys (patient surveys) and Allergan Patient Information Form (patient information form) to describe:

1. Patient demographics
2. Treatment patterns
3. Patient feedback and overall experience with MMS treatment

Study Overview

• Status: Withdrawn
• Conditions: Body Fat Disorder
• Intervention / Treatment: Other: Questionnaire review

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Subject has received MMS treatment in the abdomen and/or buttocks (with CoolTone prototype)
• Subject has completed the Allergan patient survey and information form on MMS experience between July 1, 2019 and December 1, 2019.

Exclusion Criteria

• There are no exclusion criteria for this study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Questionnaire Review	Other: Questionnaire review; Review data from questionnaires received about MMS experience.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Endpoint: Overall Experience Questionnaire	Evaluation of patient overall experience with MMS treatment as measured by patient survey.	Immediately post subjects final treatment.

Collaborators and Investigators

• Sponsor: Zeltiq Aesthetics
• Investigators: Study Director: Kerrie Jiang, NP, Zeltiq Aesthetics

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: ZA19-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No