CompletedNot Applicable

Pilot Study on the Submental Area

United States14 participantsStarted 2013-10

Plain-language summary

The purpose of this study is to evaluate the safety and feasibility of cryolipolysis for non-invasive reduction of submental fat.

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)

Timeframe: 8-weeks post treatment

NCT IDNCT01859091

SponsorZeltiq Aesthetics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-10

Results submitted2015-10-23