Quadrivas Therapy® to Reduce Lipedema Subcutaneous Adipose Tissue (QUADRIVAS) (QUADRIVAS)
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|ClinicalTrials.gov Identifier: NCT02907411|
Recruitment Status : Completed
First Posted : September 20, 2016
Last Update Posted : September 15, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Lipedema||Other: Quadrivas Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Quadrivas Therapy® to Reduce Lipedema Subcutaneous Adipose Tissue (QUADRIVAS)|
|Study Start Date :||September 1, 2016|
|Actual Primary Completion Date :||March 18, 2017|
|Actual Study Completion Date :||March 18, 2017|
Experimental: Quadrivas Therapy
Hands on therapy to improve all aspects of fat tissue including the vessels within. Each of 7 subjects receive 12 treatments in one month time.
Other: Quadrivas Therapy
Quadrivas therapy will be applied to subjects. Quadrivas therapy is a intensive massage therapy for different tissues. Subjects will receive 12 treatments. The first lasting 2.5 hours and the remaining 11 lasting 1.5 hours.
- Full Body Fat Percentage [ Time Frame: Baseline and 4 weeks ]Change in full body fat percentage after 4 weeks of treatment
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|Ages Eligible for Study:||19 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Ambulatory females of any race able to understand the consent process.
- 19-70 years of age.
- Diagnosis of lipedema Stage 1 or Stage 2 although early Stage 3 will be considered.
- Weight stable for past three months per personal report of the subject.
- Must be able to attend all 12 treatments and pre and post procedures
- Use of medications that might cause weight gain and prevent fat loss (e.g., second generation anti-psychotics, corticosteroids).
- Current use of weight loss medications.
- Tobacco or marijuana use which may alter inflammation in the body.
- Pregnancy due to the risks associated with deep tissue treatment.
- Two or more alcoholic beverages per day, chronically.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907411
|United States, Arizona|
|The Herbst Clinic|
|Tucson, Arizona, United States, 85711|
|Clinical and Translational Sciences Research Center (CATS) at the University of Arizona|
|Tucson, Arizona, United States, 85724-5099|
|Principal Investigator:||Karen L Herbst, MD, PhD||University of Arizona|
|Responsible Party:||KHerbst, Associate Professor, TREAT Program Director, University of Arizona|
|Other Study ID Numbers:||
|First Posted:||September 20, 2016 Key Record Dates|
|Last Update Posted:||September 15, 2017|
|Last Verified:||September 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||The data will be shared with investigators who submit a request|
Connective Tissue Diseases