IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Trial record 1 of 4 for:
"Lipedema"
Quadrivas Therapy® to Reduce Lipedema Subcutaneous Adipose Tissue (QUADRIVAS) (QUADRIVAS)
This study is ongoing, but not recruiting participants.
Sponsor:
University of Arizona
Collaborators:
Hanger Clinic
Quadrivas Therapy Clinic & Academy Amsterdam
Information provided by (Responsible Party):
KHerbst, University of Arizona
ClinicalTrials.gov Identifier:
NCT02907411
First received: September 13, 2016
Last updated: September 19, 2016
Last verified: September 2016
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Quad Rivas Therapy has been developed by Alyna Eekma from the Netherlands for over thirteen years; anecdotally she has been able to significantly reduce lipedema SAT in women with Stage 1 and 2 lipedema, and can reduce lipedema SAT by 80% in women with Stage 3 lipedema. The study will last for one month, for a total of 12 treatments per subject, seven subjects total, to see if there is a change in percent body fat percentage over the course of these treatments.
| Condition | Intervention |
|---|---|
| Lipedema | Other: Quadrivas Therapy |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Quadrivas Therapy® to Reduce Lipedema Subcutaneous Adipose Tissue (QUADRIVAS) |
Further study details as provided by KHerbst, University of Arizona:
Primary Outcome Measures:
- Full Body Fat Percentage [ Time Frame: Baseline and 4 weeks ]Change in full body fat percentage after 4 weeks of treatment
| Enrollment: | 7 |
| Study Start Date: | September 2016 |
| Estimated Study Completion Date: | October 2016 |
| Estimated Primary Completion Date: | October 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 19 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02907411
Please refer to this study by its ClinicalTrials.gov identifier: NCT02907411
Locations
| 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 | |
Sponsors and Collaborators
University of Arizona
Hanger Clinic
Quadrivas Therapy Clinic & Academy Amsterdam
Investigators
| Principal Investigator: | Karen L Herbst, MD, PhD | University of Arizona |
More Information
Additional Information:
| Responsible Party: | KHerbst, Associate Professor, TREAT Program Director, University of Arizona |
| ClinicalTrials.gov Identifier: | NCT02907411 History of Changes |
| Other Study ID Numbers: |
1607696709 |
| Study First Received: | September 13, 2016 |
| Last Updated: | September 19, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | The data will be shared with investigators who submit a request |
Keywords provided by KHerbst, University of Arizona:
|
Quadrivas Veins Lipedema Lymphedema |
Additional relevant MeSH terms:
|
Lipedema Connective Tissue Diseases |
ClinicalTrials.gov processed this record on July 14, 2017