A Study to Assess Non-Invasive Subcutaneous Fat Reduction in the Submental, Inner Thigh and Back/Bra Areas With the CoolSculpting Elite System

AbbVie

Status and phase: Active, not recruiting; Phase 4

Conditions: Non-Surgical Fat Reduction

Treatments: Device: CoolSculpting Elite System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07122583

M25-970

ZA24-002 (Other Identifier)

Details and patient eligibility

About

The primary objective of this protocol is the continued collection of data specific to the submental, inner thigh and back/bra body areas with CoolSculpting Elite. The study aims to collect post-market safety data while allowing for the collection of standardized photos and satisfaction questionnaires after treatment with commercial treatment parameters.

Enrollment: 102 patients

Sex: All

Ages: 22 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant has clearly visible fat on the submental, bilateral inner thigh or bilateral back/bra areas, which in the investigator's opinion, is appropriate for treatment with CoolSculpting Elite.
• Participant has not had weight change exceeding 5% of body weight in the preceding month.

Exclusion criteria

• Participant has had a recent surgical procedure in the area of intended treatment within the previous 6 months.
• Participant has had previous surgical or invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
• Participant has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the previous 12 months.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 3 patient groups

Cohort A: Submental

Other group

Description:

Participants will receive applications of the CoolSculpting Elite System in the submental body area.

Treatment:

Device: CoolSculpting Elite System

Cohort B: Inner Thigh

Other group

Description:

Participants will receive applications of the CoolSculpting Elite System in the inner thigh (bilateral) body area.

Treatment:

Device: CoolSculpting Elite System

Cohort C: Back/Bra

Other group

Description:

Participants will receive applications of the CoolSculpting Elite System in the back/bra (bilateral) body area.

Treatment:

Device: CoolSculpting Elite System