NCT01579487

Brief Summary

This study is being performed to follow up on subjects who participated in the initial study (ZA10-001) in 2010.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2012

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

June 22, 2017

Status Verified

March 1, 2012

Enrollment Period

1 month

First QC Date

March 15, 2012

Last Update Submit

June 20, 2017

Conditions

Body Fat Disorder

Keywords

LipolysisCryolipolysisFat Reduction

Outcome Measures

Primary Outcomes (1)

  • Independent Photo Review

    The primary effectiveness endpoint is the correct identification of the series of pre-treatment images by the three reviewers.

    12+ mos post treatment

Secondary Outcomes (2)

  • Access reduction

    12+ mos post treatment

  • Subject Satisfaction

    12+ mos post treatment

Interventions

The Zeltiq SystemDEVICE

This is a follow-up study from the initial treatments performed in 2010. No additional treatments will be performed.

Also known as: Cryolipolysis, Lipolysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject participated in the ZA10-001 study, and received all study treatments.
  • Subject has read and signed a written informed consent form.

You may not qualify if:

  • Subject has had any surgical or aesthetic procedure(s) in or around the abdomen since the completion of the ZA10-001 study treatments.
  • Subject is pregnant.
  • Subject is unable or unwilling to comply with the study requirements.
  • Subject is 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 integrity of the data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayoral Dermatology

Coral Gables, Florida, 33143, United States

Location

MeSH Terms

Interventions

Lipectomy

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsBariatric SurgeryBariatricsObesity ManagementSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Flor Mayoral, MD

    Mayoral Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2012

First Posted

April 18, 2012

Study Start

March 1, 2012

Primary Completion

April 1, 2012

Study Completion

February 1, 2013

Last Updated

June 22, 2017

Record last verified: 2012-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)