Body Fat DisorderNCT04199806
Retrospective Study of Patient Surveys
A study testing Questionnaire review in people with Body Fat Disorder, run by Zeltiq Aesthetics.
Trial summary
To collect data from Allergan Patient Surveys (patient surveys) and Allergan Patient Information Form (patient information form) to describe: 1. Patient demographics 2. Treatment patterns 3. Patient feedback and overall experience with MMS treatment Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Fat Disorder
- What is being tested?
- Questionnaire review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 Nov 2019to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has received MMS treatment in the abdomen and/or buttocks (with CoolTone prototype)
- Subject has completed the Allergan patient survey and information form on MMS experience between July 1, 2019 and December 1, 2019.
Who cannot join
- There are no exclusion criteria for this study.
About this study
Official title: Retrospective Study of Patient Surveys of MMS Experience
To collect data from Allergan Patient Surveys (patient surveys) and Allergan Patient Information Form (patient information form) to describe:
- Patient demographics
- Treatment patterns
- Patient feedback and overall experience with MMS treatment
- Conditions
- Body Fat Disorder
- Being tested
- Questionnaire review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire reviewOther
Review data from questionnaires received about MMS experience.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire Review | Other | Not described Receives: Other: Questionnaire review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Endpoint: Overall Experience Questionnaire
Evaluation of patient overall experience with MMS treatment as measured by patient survey.
Measured: Immediately post subjects final treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start22 Nov 2019
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Why it stopped: This is a retrospective study reviewing subject questionnaires. No treatments will be administered in this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Fat DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeltiq Aesthetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kerrie Jiang, NP, Study director, Zeltiq Aesthetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199806
- Sponsor's protocol ID
- ZA19-004
- Status last verified
- Dec 2019
- First submitted
- 3 Dec 2019
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Patient Surveys of MMS Experience
- ClinicalTrials.gov ID
- NCT04199806
- Acronym / sponsor ID
- ZA19-004
- Conditions
- Body Fat Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This is a retrospective study reviewing subject questionnaires. No treatments will be administered in this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zeltiq AestheticsIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To collect data from Allergan Patient Surveys (patient surveys) and Allergan Patient Information Form (patient information form) to describe:
- Patient demographics
- Treatment patterns
- Patient feedback and overall experience with MMS treatment
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire Review | Other | Other: Questionnaire review |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has received MMS treatment in the abdomen and/or buttocks (with CoolTone prototype)
- Subject has completed the Allergan patient survey and information form on MMS experience between July 1, 2019 and December 1, 2019.
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire reviewReview data from questionnaires received about MMS experience. | Other | Questionnaire Review |
Primary outcome
Efficacy Endpoint: Overall Experience Questionnaire
Time frame: Immediately post subjects final treatment.
Evaluation of patient overall experience with MMS treatment as measured by patient survey.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerrie Jiang, NP study director
Zeltiq Aesthetics
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire review in people with Body Fat Disorder, run by Zeltiq Aesthetics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Endpoint: Overall Experience Questionnaire (time frame: Immediately post subjects final treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.