Back to resultsRetrospective Study of Patient Surveys
Primary Purpose
Body Fat Disorder
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Questionnaire review
Sponsored by
About this trial
This is an interventional other trial for Body Fat Disorder
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Questionnaire Review
Arm Description
Outcomes
Primary Outcome Measures
Efficacy Endpoint: Overall Experience Questionnaire
Evaluation of patient overall experience with MMS treatment as measured by patient survey.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04199806
Brief Title
Retrospective Study of Patient Surveys
Official Title
Retrospective Study of Patient Surveys of MMS Experience
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Withdrawn
Why Stopped
This is a retrospective study reviewing subject questionnaires. No treatments will be administered in this study.
Study Start Date
November 22, 2019 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zeltiq Aesthetics
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
To collect data from Allergan Patient Surveys (patient surveys) and Allergan Patient Information Form (patient information form) to describe:
Patient demographics
Treatment patterns
Patient feedback and overall experience with MMS treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Fat Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Questionnaire Review
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Questionnaire review
Intervention Description
Review data from questionnaires received about MMS experience.
Primary Outcome Measure Information:
Title
Efficacy Endpoint: Overall Experience Questionnaire
Description
Evaluation of patient overall experience with MMS treatment as measured by patient survey.
Time Frame
Immediately post subjects final treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerrie Jiang, NP
Organizational Affiliation
Zeltiq Aesthetics
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Retrospective Study of Patient Surveys
We'll reach out to this number within 24 hrs