LiposuctionHarmonicLipoNCT07889427
A Prospective Randomized Study to Evaluate the Benefits of Harmonic Vibration Liposuction
An observational study of Liposuction and Body Contouring Surgery, run by Lipocosm, LLC at 1 site in United States.
Trial summary
The purpose of this study is to compare two devices, PAL device manufactured by Microaire Surgical Instruments, LLC and the Harmonic Vibrator liposuction device to see if there is a difference in the outcome of the procedure with either device. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liposuction, Body Contouring Surgery
- What is being tested?
- Harmonic Vibration
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2019to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Study population will be selected from Miami Breast Center patient population residing in South Florida region.
Who may be able to join
- Male or female 18 - 80 years of age.
- Willingness, ability and commitment to participate in baseline and follow-up evaluations.
- Signed patient informed consent form.
Who cannot join
- Acute illness or active systemic infection or sepsis.
- History of Hepatitis C or HIV/AIDS.
- Women who are pregnant or breast feeding -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare two devices, PAL device manufactured by Microaire Surgical Instruments, LLC and the Harmonic Vibrator liposuction device to see if there is a difference in the outcome of the procedure with either device. The PAL device will be used on one side of the body and the investigational Harmonic Vibrator device on the other side of the body.
Read the detailed description
Liposuction is a cosmetic surgical procedure, which removes unwanted areas of subcutaneous fat using a small stainless steel suction cannula connected to a strong vacuum by plastic tubing. The cannula is inserted into subcutaneous fat through tiny incisions, which eventually become imperceptible. When a strong suction is applied and the cannula is moved in a reciprocating in-an-out motion, subcutaneous fat is aspirated into a disposable canister.
Harvesting with the standard liposuction, or even the more efficient reciprocating PAL device, consists of plowing back and forth through the same narrow axial channel in one dimension. This tends to over harvest from that one groove and the resultant unevenness is the cause of most liposuction complications. In contrast, with each stroke, a harmonically vibrating cannula harvests from a wider three-dimensional volume of tissue. The result is like fishing with a spear compared to throwing a net, or hunting birds with a rifle instead of a shotgun.
According to the American Society of Plastic Surgeons (ASPS), liposuction is performed in over 258,000 procedures in 2018. Liposuction can be performed on the hips and buttocks, upper arms, abdomen and waist, thighs, back and chest. Although liposuction is a safe procedure when it is performed properly, some complications, such as skin irregularities, extended edema, changes to skin sensitivity, seromas, fat embolism, sepsis may occur.
One of the major issues with the current procedure is liposuction deformity complications. Initial research using a prototype Harmonic Harvester in more than 100 procedures, demonstrated that much less post liposuction contour deformities were observed; and no complications attributable to the liposuction were reported. In addition, the harvesting is much more efficient (more volume of fat harvested per minute of liposuction); the harvested fat seems to be better grafting material, probably richer in stem cells, as our grafting results have improved.
A liposuction cannula harmonically vibrating (HV) between 30 and 80Hz is most efficient at harvesting fat. Furthermore, we also hypothesize that compared to the standard liposuction or the power assisted liposuction (PAL), HV harvests better quality fat with less contour deformity complications.
The primary objective is to evaluate the merits of the liposuction cannula harmonically vibrating in liposuction compared to the PAL assisted liposuction.
The study is designed as a prospective, multicenter, crossover study. Each patient will have symmetric areas liposuctioned by HV on one side of the body and PAL assisted liposuction on the other side. The subjects will be blinded to study treatment for the duration of the study period.
A total of 12 subjects at up to 2 investigative sites will be enrolled and equally (1:1) randomized between those undergoing HV vs. those treated using PAL assisted liposuction.
Overall study duration (first subject enrolled through last subject exit) will be comprised of approximately 1 - 2 weeks of enrollment period. Study duration for an individual subject, once consented, will be 30 days for follow-up after treatment.
Primary Safety Endpoints Endpoint: Acute success Description: Freedom from procedure-related serious adverse events within 7 days of the procedure.
Primary Effectiveness Endpoints Endpoint: Volume of fat aspirated per minute Definition: The lipoaspirate will be collected in the standard Lipografter bags and allowed to sediment for 15 minutes and the supernatant fat collected and its volume measured. The volume of fat collected during 12 minutes of liposuction will be calculated.
Endpoint: ADSC count per ml of lipoaspirate (after enzymatic isolation \& culture) Definition: Stem cell colony count per ml of lipoaspirate after collagenase and trypsin enzymatic digestion
Endpoint: Contour analysis of the liposuction sites, 1 month post-op Definition: Sum of the Likert scale (1-5) visual contour irregularity graded by the patient and the surgeon.
7.1 SELECTION CRITERIA The criteria listed below shall be used to determine if a participant is eligible for entry into the study. A subject must meet ALL of the study inclusion criteria and NONE of the study exclusion criteria in order to be considered eligible for participation.
- Inclusion Criteria
Subjects are required to meet the following inclusion criteria:
- Male or female 18 - 80 years of age.
- Willingness, ability and commitment to participate in baseline and follow-up evaluations.
- Signed patient informed consent form. B. Exclusion Criteria
Subjects must NOT meet any of the following exclusion criteria:
- Acute illness or active systemic infection or sepsis.
- History of Hepatitis C or HIV/AIDS.
- Women who are pregnant or breast feeding
- Conditions
- Liposuction, Body Contouring Surgery
- Being tested
- Harmonic Vibration
- Keywords
- Power assisted liposuction, liposuction, harmonic vibration, lipoaspirate, body contouring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harmonic VibrationDevice
Harmonic Vibration Liposuction Device
| Study group | Role | What they receive |
|---|---|---|
| Harmonic Vibration | Harmonic Vibration assisted Liposuction Receives: Device: Harmonic Vibration | |
| PAL assisted Liposuction | PAL device by Microaire assisted Liposuction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute success
Freedom from procedure-related serious adverse events within 7 days of the procedure.
Measured: Study duration for an individual subject, once consented, will be 30 days for follow-up after treatment.
Secondary outcomes (3)
Volume of fat aspirated per minute
The lipoaspirate will be collected in the standard Lipografter bags and allowed to sediment for 15 minutes and the supernatant fat collected and its volume measured. The volume of fat collected during 12 minutes of liposuction will be calculated.
Measured: Study duration for an individual subject, once consented, will be 30 days for follow-up after treatment.
ADSC count per ml of lipoaspirate (after enzymatic isolation & culture)
Stem cell colony count per ml of lipoaspirate after collagenase and trypsin enzymatic digestion
Measured: Study duration for an individual subject, once consented, will be 30 days for follow-up after treatment.
Contour analysis of the liposuction sites, 1 month post-op
Sum of the Likert scale (1-5) visual contour irregularity graded by the patient and the surgeon.
Measured: Study duration for an individual subject, once consented, will be 30 days for follow-up after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start26 Jul 2019
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LiposuctionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lipocosm, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard D'Amico, MD, FACS, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889427
- Sponsor's protocol ID
- CLP-00001-R001
- Acronym
- HarmonicLipo
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
International Society of Aesthetic Plastic Surgery. ISAPS International Survey on Aesthetic/Cosmetic Procedures Performed in 2023. Mount Royal, NJ: ISAPS; 2024. 2. Kalaaji A, et al. Trends in Surgical and Nonsurgical Aesthetic Procedures: A 14-Year Analysis of the International Society of Aesthetic Plastic Surgery-ISAPS. Aesthetic Plast Surg. 2024. doi:10.1007/s00266-024-04260-2. 3. Fodor PB, Vogt P. Power-assisted lipoplasty (PAL): a clinical pilot study comparing PAL to traditional lipoplasty (TL). Aesthetic Plast Surg. 1999;23(6):379-385. 4. Fodor PB. Power-assisted lipoplasty. Aesthet Surg J. 2001;21(1):90-92. 5. Fodor PB, Watson JP. Personal experience with ultrasound-assisted lipoplasty: a pilot study comparing ultrasound-assisted lipoplasty with traditional lipoplasty. Plast Reconstr Surg. 1998;101(4):1103-1116. 6. Grippaudo FR, Matarese RM, Macone A, Mazzocchi M, Scuderi N. Effects of traditional and ultrasonic liposuction on adipose tissue: a biochemical approach. Plast Reconstr Surg. 2000;106(1):197-201. 7. Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006;118(3 Suppl):108S-120S. 8. Coleman SR. Long-term survival of fat transplants: controlled demonstrations. Aesthetic Plast Surg. 1995;19(5):421-425. 9. Zuk PA, Zhu M, Mizuno H, et al. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001;7(2):211-228. 10. Khouri RK, Eisenmann-Klein M, Cardoso E, et al. Brava and autologous fat transfer is a safe and effective breast augmentation alternative: results of a 6-year, 81-patient, prospective multicenter study. Plast Reconstr Surg. 2012;129(5):1173-1187. 11. Klein JA. The tumescent technique for liposuction surgery. J Am Acad Cosmet Surg. 1987;4:263-267. 12. Caggiati A, Germani A, Di Carlo A, Borsellino G, Capogrossi MC, Picozza M. "Naturally Adipose Stromal Cell-Enriched Fat Graft: Comparative Polychromatic Flow Cytometry Study of Fat Harvested by Barbed or Blunt Multihole
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study to Evaluate the Benefits of Harmonic Vibration Liposuction
- ClinicalTrials.gov ID
- NCT07889427
- Acronym / sponsor ID
- HarmonicLipo / CLP-00001-R001
- Conditions
- Liposuction, Body Contouring Surgery
- Keywords
- Power assisted liposuction, liposuction, harmonic vibration, lipoaspirate, body contouring
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Lipocosm, LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2019 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Oct 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.
The purpose of this study is to compare two devices, PAL device manufactured by Microaire Surgical Instruments, LLC and the Harmonic Vibrator liposuction device to see if there is a difference in the outcome of the procedure with either device. The PAL device will be used on one side of the body and the investigational Harmonic Vibrator device on the other side of the body.
Detailed description
Liposuction is a cosmetic surgical procedure, which removes unwanted areas of subcutaneous fat using a small stainless steel suction cannula connected to a strong vacuum by plastic tubing. The cannula is inserted into subcutaneous fat through tiny incisions, which eventually become imperceptible. When a strong suction is applied and the cannula is moved in a reciprocating in-an-out motion, subcutaneous fat is aspirated into a disposable canister.
Harvesting with the standard liposuction, or even the more efficient reciprocating PAL device, consists of plowing back and forth through the same narrow axial channel in one dimension. This tends to over harvest from that one groove and the resultant unevenness is the cause of most liposuction complications. In contrast, with each stroke, a harmonically vibrating cannula harvests from a wider three-dimensional volume of tissue. The result is like fishing with a spear compared to throwing a net, or hunting birds with a rifle instead of a shotgun.
According to the American Society of Plastic Surgeons (ASPS), liposuction is performed in over 258,000 procedures in 2018. Liposuction can be performed on the hips and buttocks, upper arms, abdomen and waist, thighs, back and chest. Although liposuction is a safe procedure when it is performed properly, some complications, such as skin irregularities, extended edema, changes to skin sensitivity, seromas, fat embolism, sepsis may occur.
One of the major issues with the current procedure is liposuction deformity complications. Initial research using a prototype Harmonic Harvester in more than 100 procedures, demonstrated that much less post liposuction contour deformities were observed; and no complications attributable to the liposuction were reported. In addition, the harvesting is much more efficient (more volume of fat harvested per minute of liposuction); the harvested fat seems to be better grafting material, probably richer in stem cells, as our grafting results have improved.
A liposuction cannula harmonically vibrating (HV) between 30 and 80Hz is most efficient at harvesting fat. Furthermore, we also hypothesize that compared to the standard liposuction or the power assisted liposuction (PAL), HV harvests better quality fat with less contour deformity complications.
The primary objective is to evaluate the merits of the liposuction cannula harmonically vibrating in liposuction compared to the PAL assisted liposuction.
The study is designed as a prospective, multicenter, crossover study. Each patient will have symmetric areas liposuctioned by HV on one side of the body and PAL assisted liposuction on the other side. The subjects will be blinded to study treatment for the duration of the study period.
A total of 12 subjects at up to 2 investigative sites will be enrolled and equally (1:1) randomized between those undergoing HV vs. those treated using PAL assisted liposuction.
Overall study duration (first subject enrolled through last subject exit) will be comprised of approximately 1 - 2 weeks of enrollment period. Study duration for an individual subject, once consented, will be 30 days for follow-up after treatment.
Primary Safety Endpoints Endpoint: Acute success Description: Freedom from procedure-related serious adverse events within 7 days of the procedure.
Primary Effectiveness Endpoints Endpoint: Volume of fat aspirated per minute Definition: The lipoaspirate will be collected in the standard Lipografter bags and allowed to sediment for 15 minutes and the supernatant fat collected and its volume measured. The volume of fat collected during 12 minutes of liposuction will be calculated.
Endpoint: ADSC count per ml of lipoaspirate (after enzymatic isolation \& culture) Definition: Stem cell colony count per ml of lipoaspirate after collagenase and trypsin enzymatic digestion
Endpoint: Contour analysis of the liposuction sites, 1 month post-op Definition: Sum of the Likert scale (1-5) visual contour irregularity graded by the patient and the surgeon.
7.1 SELECTION CRITERIA The criteria listed below shall be used to determine if a participant is eligible for entry into the study. A subject must meet ALL of the study inclusion criteria and NONE of the study exclusion criteria in order to be considered eligible for participation.
- Inclusion Criteria
Subjects are required to meet the following inclusion criteria:
- Male or female 18 - 80 years of age.
- Willingness, ability and commitment to participate in baseline and follow-up evaluations.
- Signed patient informed consent form. B. Exclusion Criteria
Subjects must NOT meet any of the following exclusion criteria:
- Acute illness or active systemic infection or sepsis.
- History of Hepatitis C or HIV/AIDS.
- Women who are pregnant or breast feeding
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Harmonic Vibration | – | Device: Harmonic VibrationHarmonic Vibration assisted Liposuction |
| PAL assisted Liposuction | – | –PAL device by Microaire assisted Liposuction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study population will be selected from Miami Breast Center patient population residing in South Florida region.
Key inclusion criteria (3 listed)
- Male or female 18 - 80 years of age.
- Willingness, ability and commitment to participate in baseline and follow-up evaluations.
- Signed patient informed consent form.
Key exclusion criteria (3 listed)
- Acute illness or active systemic infection or sepsis.
- History of Hepatitis C or HIV/AIDS.
- Women who are pregnant or breast feeding -
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 |
|---|---|---|
| Harmonic VibrationHarmonic Vibration Liposuction Device | Device | Harmonic Vibration |
Primary outcome
Acute success
Time frame: Study duration for an individual subject, once consented, will be 30 days for follow-up after treatment.
Freedom from procedure-related serious adverse events within 7 days of the procedure.
3 secondary outcomes
Volume of fat aspirated per minute
Time frame: Study duration for an individual subject, once consented, will be 30 days for follow-up after treatment.
ADSC count per ml of lipoaspirate (after enzymatic isolation & culture)
Time frame: Study duration for an individual subject, once consented, will be 30 days for follow-up after treatment.
Contour analysis of the liposuction sites, 1 month post-op
Time frame: Study duration for an individual subject, once consented, will be 30 days for follow-up after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- BackgroundInternational Society of Aesthetic Plastic Surgery. ISAPS International Survey on Aesthetic/Cosmetic Procedures Performed in 2023. Mount Royal, NJ: ISAPS; 2024. 2. Kalaaji A, et al. Trends in Surgical and Nonsurgical Aesthetic Procedures: A 14-Year Analysis of the International Society of Aesthetic Plastic Surgery-ISAPS. Aesthetic Plast Surg. 2024. doi:10.1007/s00266-024-04260-2. 3. Fodor PB, Vogt P. Power-assisted lipoplasty (PAL): a clinical pilot study comparing PAL to traditional lipoplasty (TL). Aesthetic Plast Surg. 1999;23(6):379-385. 4. Fodor PB. Power-assisted lipoplasty. Aesthet Surg J. 2001;21(1):90-92. 5. Fodor PB, Watson JP. Personal experience with ultrasound-assisted lipoplasty: a pilot study comparing ultrasound-assisted lipoplasty with traditional lipoplasty. Plast Reconstr Surg. 1998;101(4):1103-1116. 6. Grippaudo FR, Matarese RM, Macone A, Mazzocchi M, Scuderi N. Effects of traditional and ultrasonic liposuction on adipose tissue: a biochemical approach. Plast Reconstr Surg. 2000;106(1):197-201. 7. Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006;118(3 Suppl):108S-120S. 8. Coleman SR. Long-term survival of fat transplants: controlled demonstrations. Aesthetic Plast Surg. 1995;19(5):421-425. 9. Zuk PA, Zhu M, Mizuno H, et al. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001;7(2):211-228. 10. Khouri RK, Eisenmann-Klein M, Cardoso E, et al. Brava and autologous fat transfer is a safe and effective breast augmentation alternative: results of a 6-year, 81-patient, prospective multicenter study. Plast Reconstr Surg. 2012;129(5):1173-1187. 11. Klein JA. The tumescent technique for liposuction surgery. J Am Acad Cosmet Surg. 1987;4:263-267. 12. Caggiati A, Germani A, Di Carlo A, Borsellino G, Capogrossi MC, Picozza M. "Naturally Adipose Stromal Cell-Enriched Fat Graft: Comparative Polychromatic Flow Cytometry Study of Fat Harvested by Barbed or Blunt Multihole
- Individual participant dataSharing planned: Yes
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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.
Richard D'Amico, MD, FACS principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liposuction and Body Contouring Surgery, run by Lipocosm, LLC at 1 site in United States.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 22 Oct 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Acute success (time frame: Study duration for an individual subject, once consented, will be 30 days for follow-up after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07889427, which also lists 1 linked publication.
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 22 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.