Retrospective Study of Patient Surveys | NCT04199806

Studies
Retrospective Study of Patient Surveys

NCT04199806

Sponsor

Zeltiq Aesthetics

Status

Withdrawn

Last Update Posted

Dec 16, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Body Fat Disorder

Interventions

Questionnaire review

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This is a retrospective study reviewing subject questionnaires. No treatments will be administered in this study.

Expanded Access Info

Start Date

Nov 22, 2019Actual

Primary Completion Date

Jun 2020Estimated

Completion Date

Jun 2020Estimated

First Submitted Date

Dec 3, 2019

First Submission Date that Met QC Criteria

Dec 12, 2019

First Posted Date

Dec 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2019

Last Update Posted Date

Dec 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Questionnaire Review	Other		Other: Questionnaire review

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire review	Other	Review data from questionnaires received about MMS experience.	Questionnaire Review

Outcomes Module

Primary Outcomes

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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kerrie Jiang, NP	Zeltiq Aesthetics	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided