Pilot Study on the Submental Area | NCT01859091

NCT01859091

Protocol Section

Identification Module

Results Section

Participant Flow Module

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

Status Module

Oversight Module

Label	Type	Description	Intervention Names
Fat Reduction	Experimental		Device: The Zeltiq System

Name	Type	Description	Arm Group Labels	Other Names
The Zeltiq System	Device	Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.	Fat Reduction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)	An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious adverse event (SAE) was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An ADE was any sign, symptom, or disease that was determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of an SAE.	8-weeks post treatment

Secondary Outcomes

Measure	Description	Time Frame
Change in the Fat Layer of the Treated Area as Measured by Ultrasound	Change in the fat layer thickness will be calculated by comparison of pre-treatment and 8-week post-treatment ultrasound measurements taken in the area treated with the device, and in the adjacent untreated control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in control (untreated area) from the change in treated area to remove the influence of weight variations. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated region as compared to the untreated control. Results indicate the mean fat layer reduction in mm.

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Male or female subjects > 18 years of age and < 65 years of age.
Presence of submental fat, which in the investigator's opinion, may benefit from the treatment.
No weight change exceeding 10 pounds in the preceding month.
Agreement to maintain his/her weight (i.e., within 10 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
Subject has signed a written informed consent form.

Exclusion Criteria

Skin laxity in the neck or chin area for which reduction in submental fat may.
Evidence of any cause of enlargement in the submental area other than localized subcutaneous fat.
Enlargement on the anterior neck that may prevent the proper placement of the applicator.
Treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the neck or chin area.
Botulinum toxin injections within the neck or chin area.
History of a fat reduction procedure in the area of intended treatment.
History of prior surgery in the area of intended treatment.
Current dental infection.
Known history of cryoglobulinemia, cold urticaria, 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.
Impaired skin sensation or thermal sensitivity in the intended treatment area.
Open or infected wounds in the intended treatment area.
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, defibrillator, or drug delivery system.
Pregnant or intending to become pregnant in the next 5 months.
Lactating or has been lactating in the past 6 months.
Unable or unwilling to comply with the study requirements.
Currently enrolled in a clinical study of any other 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.

Facility	Status	City	State	ZIP	Country	Contacts
Innovation Research Center		Pleasanton	California	94588	United States

ID	Title	Description
FG000	Fat Reduction	The Zeltiq System: Non-invasive cooling applied to the treatment area with a defined cooling rate and duration.

Baseline Characteristics Module

ID	Title	Description
BG000	Fat Reduction	The Zeltiq System: Non-invasive cooling applied to the treatment area with a defined cooling rate and duration.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type	Title	Description	Population Description	Reporting Status	Anticipated Posting Date	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Time Frame	Units Analyzed	Denominator Units Selected	Arm/Group Information	Denominators	Classes	Analyses
Primary	Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)	An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious adverse event (SAE) was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An ADE was any sign, symptom, or disease that was determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of an SAE.	All enrolled subjects (Fat Reduction group) who received treatment.	Posted		Number		participants		8-weeks post treatment

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Fat Reduction	The Zeltiq System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.

ID	Term
D003357	Cosmetic Techniques
D013812	Therapeutics
D050110	Bariatric Surgery
D049088	Bariatrics