LipedemaNCT07404059
Effect of Ultrasound Cavitation Versus Pneumatic Compression on Adipose Tissue Thickness on Lipedema Patients
A study testing fat cavitation in people with Lipedema, run by Cairo University at 1 site in Egypt.
Trial summary
PURPOSE: This study will be conducted to investigate any significant effect of ultrasound fat cavitation or pneumatic compression on adipose tissue thickness in patients with lipedema. BACKGROUND: Lipedema is a connective tissue disorder that cause physical discomfort and psychological stress. Read more about this study
- Who is it for?
- Ages 30 to 45 years, women only
- Conditions the study is for
- Lipedema
- What is being tested?
- fat cavitation
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteEgypt
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 30 to 45 years
- Women only
- Adult
Who may be able to join
- Ninety females patients their age from 30 to 45 years
- Diagnosed with mild to moderate lipedema
- Mentally stable functionally and physically stable.
Who cannot join
- Patents with severe lipedema
- Patients with type 4 lipedema
- Clinically unstable patients
- Patients with chronic diseases
- Patients with endocrine diseases
- Patienst with similar conditions like lymphedema, dercum's diseases or overall obesity
- Patients with lower limbs fractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Fat Cavitation Versus Pneumatic Compression on Adipose Tissue Thickness in Patients With Lipedema
PURPOSE:
This study will be conducted to investigate any significant effect of ultrasound fat cavitation or pneumatic compression on adipose tissue thickness in patients with lipedema.
Read more
BACKGROUND:
Lipedema is a connective tissue disorder that cause physical discomfort and psychological stress.
A literature review published in 2020 estimated that 10-11% of women or approximately 400 million women across the globe have lipedema.
Lipedema fat is dangerous when it progress onto abdomen and trunk resulting in a risk of developing high blood pressure, high cholesterol and diabetes.
Ultrasound cavitation is a safe cosmetic procedure has almost no adverse reactions used to break down fat cells under the skin which improves the body shape and reduce circumference which make it a promising non invasive tool alternative to surgical liposuction.
Pneumatic compression is bl=elieved to reduce the limb circumference and volume which make it a good treatment option for lipedema.
HYPOTHESES:
Null Hypothesis:there will be no significant effect of fat cavitation or pneumatic compression on the adipose tissue thickness in patients with lipedema.
RESEARCH QUESTION:Will be any significant effect of fat cavitation or pneumatic compression on the adipose tissue thickness in patients with lipedema
Read the detailed description
Lipedema is a progressive disease. There are currently 3 primary stages that describe disease severity: stage 1 involves thickening of subcutaneous tissue and disproportion accumulation of subcutaneous tissue in the extremities (tissue remains smooth and is generally not heavy or swollen); stage 2 is characterized by increased fibrous tissue, leading to a nodular feel in the subcutaneous tissue. Symptomatic lipedema patients at stage 2 and higher almost always have secondary swelling on physical exam and most with evidence of impaired lymphatic function. Stage 3 involves progression with the formation of lobules of skin and subcutaneous tissue Conservative therapies, including manual lymphatic drainage, compression therapy, decongestive sports/movement therapy, skin care, and empowerment are currently considered as first line treatments (2-4). Surgical reduction of pathological SAT with lymph-sparing liposuction in wet-technique is another potential therapeutic option to improve symptoms, mobility and overall quality of life The most promising techniques for noninvasive body sculpturing purposes are based on ultrasound-induced fat cavitation. Liporeductive ultrasound devices afford clinically relevant subcutaneous fat pad reduction without significant adverse reactions, noninvasive transcutaneous ultrasound cavitation is a promising and safe technology for localized reduction of fat and provides experimental evidence for its specific mechanism of action on the adipocytes. the most effective instruments for noninvasive fat reduction use ultrasounds through the generation of compression and depression cycles at appropriate frequency, they cause cavitation phenomena at the fat droplet-watery cytoplasm interface and eventually adipocyte rupture and triglyceride release. the thermal effects of focused ultrasound energy may result in adipocyte necrosis in the treatment area. The most recent devices for liporeductive purposes have been specifically designed to prevent unwanted tissue injury. a focused ultrasound emitter, was first demonstrated to achieve selective adipocyte lysis and clinically relevant reduction of the volume of subcutaneous fat pad, in the absence of significant adverse reactions.
Pneumatic compression devices move lymphatic fluid and support the elimination of proteinaceous fluids, thus leading to improved patient-reported symptoms, decreased limb girth and volume, increased elasticity of tissues, and fewer episodes of infection. Atan et al. found improvements in limb volume, pain, and physical functioning in patients with stage 3 or 4 lipedema after CDT or PCD treatmentSzolnoky reported daily treatment with CDT, PCD, and multilayered short-stretch bandaging performed for 5 days led to significant improvements in leg volume, capillary fragility, and pain in women with lipedema 90 patients will participate in the study for 3 months, and randomly be assigned into 3 equal groups. Study Group (A), (n =30) will receive fat cavitation 2 times /week for 3 months in addition to the complete decongestive therapy , study group (B), (n =30) will receive pneumatic compression 3-5 times /week in addition to the complete decongestive therapy, and control group (c), (n=30) will receive the complete decongestive therapy only.
Hypothesis:
This study will test the following hypothesis:
- There is no effect of cavitation on the adipose tissue thickness in patients with lipedema.
- There is no effect of pneumatic compression on adipose tissue thickness in patients with lipedema.
Basic assumption:
- It will be assumed that:
- All patients will be free from any condition that may affect or delay the response to our program such as diabetes, open wound or hypertension.
- The assessment methods will be valid and reliable.
- All patient will be accurately diagnosed and exclude any other similar conditions as lymphedema, lipohypertrophy or Dercum's disease.
- All patients will be cooperative during the assessment and treatment.
- Conditions
- Lipedema
- Being tested
- fat cavitation
- Keywords
- pneumatic compression, fat cavitation, lipedema
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fat cavitationDevice
fat cavitation is a device produces ultrasound waves used for fat lipolysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Mohamed Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404059
- Sponsor's protocol ID
- lipedema
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fat Cavitation Versus Pneumatic Compression on Adipose Tissue Thickness in Patients With Lipedema
- ClinicalTrials.gov ID
- NCT07404059
- Acronym / sponsor ID
- lipedema
- Conditions
- Lipedema
- Keywords
- pneumatic compression, fat cavitation, lipedema
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- First posted
- 11 Feb 2026 (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.
PURPOSE:
This study will be conducted to investigate any significant effect of ultrasound fat cavitation or pneumatic compression on adipose tissue thickness in patients with lipedema.
BACKGROUND:
Lipedema is a connective tissue disorder that cause physical discomfort and psychological stress.
A literature review published in 2020 estimated that 10-11% of women or approximately 400 million women across the globe have lipedema.
Lipedema fat is dangerous when it progress onto abdomen and trunk resulting in a risk of developing high blood pressure, high cholesterol and diabetes.
Ultrasound cavitation is a safe cosmetic procedure has almost no adverse reactions used to break down fat cells under the skin which improves the body shape and reduce circumference which make it a promising non invasive tool alternative to surgical liposuction.
Pneumatic compression is bl=elieved to reduce the limb circumference and volume which make it a good treatment option for lipedema.
HYPOTHESES:
Null Hypothesis:there will be no significant effect of fat cavitation or pneumatic compression on the adipose tissue thickness in patients with lipedema.
RESEARCH QUESTION:Will be any significant effect of fat cavitation or pneumatic compression on the adipose tissue thickness in patients with lipedema
Detailed description
Lipedema is a progressive disease. There are currently 3 primary stages that describe disease severity: stage 1 involves thickening of subcutaneous tissue and disproportion accumulation of subcutaneous tissue in the extremities (tissue remains smooth and is generally not heavy or swollen); stage 2 is characterized by increased fibrous tissue, leading to a nodular feel in the subcutaneous tissue. Symptomatic lipedema patients at stage 2 and higher almost always have secondary swelling on physical exam and most with evidence of impaired lymphatic function. Stage 3 involves progression with the formation of lobules of skin and subcutaneous tissue Conservative therapies, including manual lymphatic drainage, compression therapy, decongestive sports/movement therapy, skin care, and empowerment are currently considered as first line treatments (2-4). Surgical reduction of pathological SAT with lymph-sparing liposuction in wet-technique is another potential therapeutic option to improve symptoms, mobility and overall quality of life The most promising techniques for noninvasive body sculpturing purposes are based on ultrasound-induced fat cavitation. Liporeductive ultrasound devices afford clinically relevant subcutaneous fat pad reduction without significant adverse reactions, noninvasive transcutaneous ultrasound cavitation is a promising and safe technology for localized reduction of fat and provides experimental evidence for its specific mechanism of action on the adipocytes. the most effective instruments for noninvasive fat reduction use ultrasounds through the generation of compression and depression cycles at appropriate frequency, they cause cavitation phenomena at the fat droplet-watery cytoplasm interface and eventually adipocyte rupture and triglyceride release. the thermal effects of focused ultrasound energy may result in adipocyte necrosis in the treatment area. The most recent devices for liporeductive purposes have been specifically designed to prevent unwanted tissue injury. a focused ultrasound emitter, was first demonstrated to achieve selective adipocyte lysis and clinically relevant reduction of the volume of subcutaneous fat pad, in the absence of significant adverse reactions.
Pneumatic compression devices move lymphatic fluid and support the elimination of proteinaceous fluids, thus leading to improved patient-reported symptoms, decreased limb girth and volume, increased elasticity of tissues, and fewer episodes of infection. Atan et al. found improvements in limb volume, pain, and physical functioning in patients with stage 3 or 4 lipedema after CDT or PCD treatmentSzolnoky reported daily treatment with CDT, PCD, and multilayered short-stretch bandaging performed for 5 days led to significant improvements in leg volume, capillary fragility, and pain in women with lipedema 90 patients will participate in the study for 3 months, and randomly be assigned into 3 equal groups. Study Group (A), (n =30) will receive fat cavitation 2 times /week for 3 months in addition to the complete decongestive therapy , study group (B), (n =30) will receive pneumatic compression 3-5 times /week in addition to the complete decongestive therapy, and control group (c), (n=30) will receive the complete decongestive therapy only.
Hypothesis:
This study will test the following hypothesis:
- There is no effect of cavitation on the adipose tissue thickness in patients with lipedema.
- There is no effect of pneumatic compression on adipose tissue thickness in patients with lipedema.
Basic assumption:
- It will be assumed that:
- All patients will be free from any condition that may affect or delay the response to our program such as diabetes, open wound or hypertension.
- The assessment methods will be valid and reliable.
- All patient will be accurately diagnosed and exclude any other similar conditions as lymphedema, lipohypertrophy or Dercum's disease.
- All patients will be cooperative during the assessment and treatment.
Study design
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ninety females patients their age from 30 to 45 years
- Diagnosed with mild to moderate lipedema
- Mentally stable functionally and physically stable.
Key exclusion criteria (7 listed)
- Patents with severe lipedema
- Patients with type 4 lipedema
- Clinically unstable patients
- Patients with chronic diseases
- Patients with endocrine diseases
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 |
|---|---|---|
| fat cavitationfat cavitation is a device produces ultrasound waves used for fat lipolysis | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fat cavitation in people with Lipedema, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heba abdo Badawy, phd (01025627635, hopehope5@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 11 Feb 2026.