## Protocol Section
### Identification Module
**NCT ID:** NCT03873779

**Acronym:** CRT

**Brief Title:** CoolSculpting and RF for the Submental

**Official Title:** A Feasibility Study to Explore the Safety and Efficacy of Cryolipolysis Followed by Radiofrequency Treatment for Submental and Submandibular Contouring

#### Organization Study ID Info
**ID:** ZA18-002
#### Organization
**Class:** INDUSTRY
**Full Name:** Zeltiq Aesthetics
### Status Module
#### Completion Date
**Date:** 2020-11

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2020-08-18

**Type:** ACTUAL

**Last Update Submit Date:** 2020-08-14

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2020-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-12-18

**Type:** ACTUAL

**Status Verified Date:** 2020-08

#### Study First Post Date
**Date:** 2019-03-13
**Type:** ACTUAL
**Study First Submit Date:** 2018-12-18
**Study First Submit QC Date:** 2019-03-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Zeltiq Aesthetics

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to evaluate the safety and efficacy of sequential use of CoolSculpting (Cryolipolysis) and radiofrequency treatment of the submental and submandibular area.

### Conditions Module

**Conditions:**

- Body Fat Disorder

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 25

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The treatments are designed to see if the fat can be reduced in the submental/submandibular area.

**Intervention Names:**

- Device: The ZELTIQ System

**Label:** Fat Reduction

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Fat Reduction

**Description:** The CoolSculpting machine will be used to perform the treatments.

**Name:** The ZELTIQ System

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** The primary safety endpoint is measurement of unanticipated adverse device effects. All adverse events reported during and following the treatment will be included in the safety analysis. The frequency and proportion of subjects reporting each type of adverse event will be tabulated by relationship with the treatment and severity of the event.

**Measure:** Incidence of unanticipated adverse device effects (UADE). It is expected there will be zero UADE's.

**Time Frame:** 12-weeks post final treatment

#### Secondary Outcomes

**Description:** Overall improvement in the targeted area will be assessed by the subject using the GAIS at 12-weeks post-final treatment. The assessment will consist of writing the outcome as: Very much improved; much improved; improved; no change; worse; much worse; very much worse.

**Measure:** Assessment of overall treatment outcome in submental and submandibular area using Subject-graded GAIS (SGAIS)

**Time Frame:** 12-weeks post final treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria

* Male or female subjects ≥22 years of age and ≤65 years of age.
* Treatment area skin fold thickness \> 1cm (measured by caliper).
* Dissatisfaction with the treatment area expressed by the subject as a rating of 0, 1 or 2 using the Subject Self Rating Scale (SSRS) as determined at Screening visit.
* No weight change exceeding 5% of body weight in the preceding month.
* Agreement to maintain his/her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
* Subject has signed a written informed consent form

Exclusion Criteria

* Body Mass Index ≥ 46.2 as determined at screening.
* Excessive skin laxity in the treatment area for which reduction of subcutaneous fat may, in the opinion of the investigator, result in an unacceptable aesthetic result.
* Prominent platysmal bands at rest which may interfere with assessment of treatment area.
* Evidence of any cause of enlargement in the treatment area other than localized subcutaneous fat, such as swollen lymph nodes or ptotic submandibular glands.
* Significant enlargement on the anterior neck that may prevent the proper placement of the applicator e.g. enlarged thyroid glands.
* Treatment with dermal fillers, chemical peels, radiofrequency or laser procedures that may affect contour in the treatment area within the past 6 months.
* Botulinum toxin, deoxycholic acid, or other aesthetic drug injections within the treatment area in the past 6 months.
* History of facial nerve paresis or paralysis (such as Bell's palsy).
* History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) or implant in or adjacent to the area of intended treatment.
* History of prior neck surgery, or prior surgery in the area of intended treatment.
* Current infection in and adjacent to treatment area.
* Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease or paroxysmal cold hemoglobinuria.
* Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
* History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
* Currently taking or has taken diet pills or weight control supplements within the past month.
* Any dermatological conditions, such as scars in the location of the treatment area that may interfere with the treatment or evaluation.
* Active implanted device such as a pacemaker, automatic implantable cardioverter/defibrillator (AICD), drug delivery system, or any other implantable electrical device.
* Pregnant or intending to become pregnant in the next 6 months.
* Lactating or has been lactating in the past 6 months.
* Unable or unwilling to comply with the study requirements including remaining clean shaven for all study visits.
* Currently enrolled in a clinical study of an unapproved investigational drug or device.
* Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 22 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Pleasanton

**Country:** United States

**Facility:** Innovation Research Center

**State:** California

**Zip:** 94588

#### Overall Officials

**Official 1:**

**Affiliation:** Zeltiq Aesthetics

**Name:** Kerrie Jiang, NP

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M27029

- Name: Lipid Metabolism Disorders

- Relevance: HIGH

- As Found: Fat Disorder

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000052439

- Term: Lipid Metabolism Disorders

### Misc Info Module

- Version Holder: 2024-05-24
