LipomaNCT07797270
Ultrasound-Guided Emulsification Therapy in the Clinical Treatment of Subcutaneous Lipomas
A study testing CUSA Minimally Invasive Resection in people with Lipoma, run by Chinese PLA General Hospital.
Trial summary
Background:Lipomas are the most common benign soft tissue tumors, traditionally treated by open surgical excision. However, open surgery is associated with relatively large incisions, prolonged recovery, and visible scarring. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lipoma
- What is being tested?
- CUSA Minimally Invasive Resection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jul 2028
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Aged 18 to 60 years; 2. Subcutaneous lipoma confirmed by ultrasound and needle biopsy pathology; 3. Maximum diameter of the lipoma greater than 1 cm; 4. Lipoma located on the trunk, extremities, or neck (excluding the head and face); 5. Lipoma located in the subcutaneous fat layer with a safe distance from the skin and deep tissues; 6. Patients with explicit demand for minimally invasive and cosmetic treatment; 7. Voluntarily participate in the study and sign the informed consent form; 8. Willing to cooperate with preoperative examinations, intraoperative procedures, and postoperative follow-up.
- -
Who cannot join
- Coagulation dysfunction or currently receiving anticoagulant therapy;
- Lipoma located in the head and face or within the muscle layer;
- Atypical lipoma or liposarcoma indicated by needle biopsy pathology;
- Ulceration, redness, swelling, or infection of the skin overlying the lipoma;
- Pregnant or lactating women;
- Severe dysfunction of vital organs such as the heart, liver, or kidney;
Show all 9Show fewer
- Severe mental illness or cognitive impairment;
- Previous history of surgery or radiotherapy at the same site;
- Currently participating in other clinical studies. -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ultrasound-Guided Emulsification Therapy for Subcutaneous Lipoma: A Clinical Study
Background:Lipomas are the most common benign soft tissue tumors, traditionally treated by open surgical excision. However, open surgery is associated with relatively large incisions, prolonged recovery, and visible scarring. While liposuction offers a less invasive alternative, it often achieves unsatisfactory clearance rates for lipomas with significant fibrotic components, leading to higher recurrence rates.
Study Objective:This study aims to investigate the safety and efficacy of CUSA in the minimally invasive treatment of lipomas.
Read more
Study Methods:this is a single-center, prospective clinical study. A total of 30 eligible patients with clinically diagnosed lipomas scheduled for surgical treatment will be enrolled. All participants will undergo minimally invasive tumor resection using the CUSA system. The primary outcome measure is tumor clearance rate .Secondary outcome measures include operation time, intraoperative blood loss, postoperative pain score, complication rate, recurrence rate, cosmetic outcome, and patient satisfaction. Patients will be followed up for 6 months after treatment.
Study Significance:The results of this study will provide evidence-based clinical support for the application of CUSA in the minimally invasive treatment of lipomas, particularly for lesions with abundant fibrotic components, and may help optimize treatment strategies and improve patient outcomes.
Read the detailed description
New Technology: The Cavitron Ultrasonic Surgical Aspirator (CUSA) is an emerging minimally invasive technique that utilizes high-frequency ultrasonic vibration to fragment tissue, with simultaneous saline irrigation for emulsification and immediate aspiration. Compared with conventional open excision and simple liposuction, CUSA offers the advantages of high tissue selectivity, minimal damage to surrounding blood vessels and nerves, effective fragmentation and clearance of fibrotic components, good intraoperative hemostasis, a clear operative field, the ability to operate through a small incision, rapid postoperative recovery, and inconspicuous scarring. However, its clinical safety and efficacy in the minimally invasive resection of lipomas, particularly those with abundant fibrotic components, remain to be systematically validated.
Sample Size Calculation (30 cases): This is a single-center, prospective, single-arm clinical study with the primary outcome of tumor clearance rate after CUSA minimally invasive resection of lipomas. According to previous literature, the complete clearance rate of conventional open excision is approximately 95%, while simple liposuction achieves a clearance rate of 70%-80% for fibrotic lipomas. This study assumes that the tumor clearance rate of CUSA minimally invasive treatment is no less than 90%. With a two-sided significance level α = 0.05 and a margin of error d = 10%, the sample size is calculated using the binomial distribution formula:
n = Z²α/2 × p(1-p) / d² Substituting p = 0.90, Zα/2 = 1.96, and d = 0.10 yields n ≈ 34.6. Accounting for an approximate 10% loss to follow-up, a total of 30 patients will be enrolled. In addition, as an exploratory study, a sample size of 30 is sufficient to assess the safety and preliminary efficacy of the CUSA technique and is comparable to the sample sizes of similar studies (20-40 cases) reported in the literature.
Statistical Analysis Methods:Analysis sets: The full analysis set (FAS), including all patients who received CUSA treatment and completed at least one postoperative assessment, will be used for efficacy analysis. The safety set (SS), including all patients who received CUSA treatment, will be used for safety analysis.
Descriptive statistics: Normally distributed continuous variables are presented as mean ± standard deviation (x̄ ± s); non-normally distributed continuous variables are presented as median (interquartile range) [M (P25, P75)]; categorical variables are presented as frequency (percentage) [n (%)].
Primary outcome analysis: The tumor clearance rate is presented as a point estimate with a 95% confidence interval (95% CI), calculated using the binomial distribution method.
Secondary outcome analysis: Continuous variables such as operation time, intraoperative blood loss, and postoperative pain score (VAS) are analyzed using descriptive statistics; categorical variables such as complication rate and recurrence rate are presented as frequency (percentage) with 95% CI.
Survival analysis: The postoperative recurrence-free survival rate is analyzed using the Kaplan-Meier method, and survival curves are plotted.
Statistical software and significance level: Statistical analysis is performed using SPSS 26.0 (IBM Corp., Armonk, NY, USA) or R 4.x software. All tests are two-sided, and P < 0.05 is considered statistically significant.
- Conditions
- Lipoma
- Being tested
- CUSA Minimally Invasive Resection
- Keywords
- Cavitron Ultrasonic Surgical Aspirator, Minimally invasive surgical procedures, Lipoma
- Medical subject headings
- Lipoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUSA Minimally Invasive ResectionDevice
CUSA Minimally Invasive Resection
| Study group | Role | What they receive |
|---|---|---|
| CUSA Group | Experimental | All enrolled patients with clinically diagnosed lipoma will undergo minimally invasive tumor resection using the Cavitron Ultrasonic Surgical Aspirator (CUSA) system through a small incision. Receives: Device: CUSA Minimally Invasive Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete resection rate of lipoma
Proportion of patients with complete resection of lipoma confirmed by postoperative ultrasound or pathological examination.
Measured: Within 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for LipomaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yukun Luo, Chinese PLA General Hospital
- Investigators
- Yukun Luo, Doctor, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797270
- Sponsor's protocol ID
- S2026-634-01
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun Y, Wang Q, Xie H. Minimally Invasive Removal of Frontal Lipoma with Endoscope. Aesthetic Plast Surg. 2026 Feb;50(3):830-838. doi: 10.1007/s00266-025-05293-x. Epub 2025 Oct 10.
PubMed 41073791Ahmad N, Bakhshi SK, Shamim MS. Use of ultrasonic aspirator for CNS tumour resection. J Pak Med Assoc. 2021 Jul;71(7):1904-1906.
PubMed 34410273Chen CY, Fang QQ, Wang XF, Zhang MX, Zhao WY, Shi BH, Wu LH, Zhang LY, Tan WQ. Madelung's Disease: Lipectomy or Liposuction? Biomed Res Int. 2018 Feb 21;2018:3975974. doi: 10.1155/2018/3975974. eCollection 2018.
PubMed 29682541Cosgrave C, Abbas S, Alexander S. Large bleeding duodenal lipoma. Gastrointest Endosc. 2024 Jul;100(1):153-155. doi: 10.1016/j.gie.2023.12.030. Epub 2023 Dec 25. No abstract available.
PubMed 38151135Yee EJ, Stewart CL, Clay MR, McCarter MM. Lipoma and Its Doppelganger: The Atypical Lipomatous Tumor/Well-Differentiated Liposarcoma. Surg Clin North Am. 2022 Aug;102(4):637-656. doi: 10.1016/j.suc.2022.04.006.
PubMed 35952693
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Emulsification Therapy for Subcutaneous Lipoma: A Clinical Study
- ClinicalTrials.gov ID
- NCT07797270
- Acronym / sponsor ID
- S2026-634-01
- Conditions
- Lipoma
- Keywords
- Cavitron Ultrasonic Surgical Aspirator, Minimally invasive surgical procedures, Lipoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 1 Sep 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.
Background:Lipomas are the most common benign soft tissue tumors, traditionally treated by open surgical excision. However, open surgery is associated with relatively large incisions, prolonged recovery, and visible scarring. While liposuction offers a less invasive alternative, it often achieves unsatisfactory clearance rates for lipomas with significant fibrotic components, leading to higher recurrence rates.
Study Objective:This study aims to investigate the safety and efficacy of CUSA in the minimally invasive treatment of lipomas.
Study Methods:this is a single-center, prospective clinical study. A total of 30 eligible patients with clinically diagnosed lipomas scheduled for surgical treatment will be enrolled. All participants will undergo minimally invasive tumor resection using the CUSA system. The primary outcome measure is tumor clearance rate .Secondary outcome measures include operation time, intraoperative blood loss, postoperative pain score, complication rate, recurrence rate, cosmetic outcome, and patient satisfaction. Patients will be followed up for 6 months after treatment.
Study Significance:The results of this study will provide evidence-based clinical support for the application of CUSA in the minimally invasive treatment of lipomas, particularly for lesions with abundant fibrotic components, and may help optimize treatment strategies and improve patient outcomes.
Detailed description
New Technology: The Cavitron Ultrasonic Surgical Aspirator (CUSA) is an emerging minimally invasive technique that utilizes high-frequency ultrasonic vibration to fragment tissue, with simultaneous saline irrigation for emulsification and immediate aspiration. Compared with conventional open excision and simple liposuction, CUSA offers the advantages of high tissue selectivity, minimal damage to surrounding blood vessels and nerves, effective fragmentation and clearance of fibrotic components, good intraoperative hemostasis, a clear operative field, the ability to operate through a small incision, rapid postoperative recovery, and inconspicuous scarring. However, its clinical safety and efficacy in the minimally invasive resection of lipomas, particularly those with abundant fibrotic components, remain to be systematically validated.
Sample Size Calculation (30 cases): This is a single-center, prospective, single-arm clinical study with the primary outcome of tumor clearance rate after CUSA minimally invasive resection of lipomas. According to previous literature, the complete clearance rate of conventional open excision is approximately 95%, while simple liposuction achieves a clearance rate of 70%-80% for fibrotic lipomas. This study assumes that the tumor clearance rate of CUSA minimally invasive treatment is no less than 90%. With a two-sided significance level α = 0.05 and a margin of error d = 10%, the sample size is calculated using the binomial distribution formula:
n = Z²α/2 × p(1-p) / d² Substituting p = 0.90, Zα/2 = 1.96, and d = 0.10 yields n ≈ 34.6. Accounting for an approximate 10% loss to follow-up, a total of 30 patients will be enrolled. In addition, as an exploratory study, a sample size of 30 is sufficient to assess the safety and preliminary efficacy of the CUSA technique and is comparable to the sample sizes of similar studies (20-40 cases) reported in the literature.
Statistical Analysis Methods:Analysis sets: The full analysis set (FAS), including all patients who received CUSA treatment and completed at least one postoperative assessment, will be used for efficacy analysis. The safety set (SS), including all patients who received CUSA treatment, will be used for safety analysis.
Descriptive statistics: Normally distributed continuous variables are presented as mean ± standard deviation (x̄ ± s); non-normally distributed continuous variables are presented as median (interquartile range) [M (P25, P75)]; categorical variables are presented as frequency (percentage) [n (%)].
Primary outcome analysis: The tumor clearance rate is presented as a point estimate with a 95% confidence interval (95% CI), calculated using the binomial distribution method.
Secondary outcome analysis: Continuous variables such as operation time, intraoperative blood loss, and postoperative pain score (VAS) are analyzed using descriptive statistics; categorical variables such as complication rate and recurrence rate are presented as frequency (percentage) with 95% CI.
Survival analysis: The postoperative recurrence-free survival rate is analyzed using the Kaplan-Meier method, and survival curves are plotted.
Statistical software and significance level: Statistical analysis is performed using SPSS 26.0 (IBM Corp., Armonk, NY, USA) or R 4.x software. All tests are two-sided, and P < 0.05 is considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CUSA Group | Experimental | Device: CUSA Minimally Invasive ResectionAll enrolled patients with clinically diagnosed lipoma will undergo minimally invasive tumor resection using the Cavitron Ultrasonic Surgical Aspirator (CUSA) system through a small incision. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. Aged 18 to 60 years; 2. Subcutaneous lipoma confirmed by ultrasound and needle biopsy pathology; 3. Maximum diameter of the lipoma greater than 1 cm; 4. Lipoma located on the trunk, extremities, or neck (excluding the head and face); 5. Lipoma located in the subcutaneous fat layer with a safe distance from the skin and deep tissues; 6. Patients with explicit demand for minimally invasive and cosmetic treatment; 7. Voluntarily participate in the study and sign the informed consent form; 8. Willing to cooperate with preoperative examinations, intraoperative procedures, and postoperative follow-up.
- -
Key exclusion criteria (9 listed)
- Coagulation dysfunction or currently receiving anticoagulant therapy;
- Lipoma located in the head and face or within the muscle layer;
- Atypical lipoma or liposarcoma indicated by needle biopsy pathology;
- Ulceration, redness, swelling, or infection of the skin overlying the lipoma;
- Pregnant or lactating women;
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 |
|---|---|---|
| CUSA Minimally Invasive ResectionCUSA Minimally Invasive Resection | Device | CUSA Group |
Primary outcome
Complete resection rate of lipoma
Time frame: Within 1 week after surgery
Proportion of patients with complete resection of lipoma confirmed by postoperative ultrasound or pathological examination.
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 1 Sep 2026.
- Background: PubMed 41073791Sun Y, Wang Q, Xie H. Minimally Invasive Removal of Frontal Lipoma with Endoscope. Aesthetic Plast Surg. 2026 Feb;50(3):830-838. doi: 10.1007/s00266-025-05293-x. Epub 2025 Oct 10.
- Background: PubMed 34410273Ahmad N, Bakhshi SK, Shamim MS. Use of ultrasonic aspirator for CNS tumour resection. J Pak Med Assoc. 2021 Jul;71(7):1904-1906.
- Background: PubMed 29682541Chen CY, Fang QQ, Wang XF, Zhang MX, Zhao WY, Shi BH, Wu LH, Zhang LY, Tan WQ. Madelung's Disease: Lipectomy or Liposuction? Biomed Res Int. 2018 Feb 21;2018:3975974. doi: 10.1155/2018/3975974. eCollection 2018.
- Background: PubMed 38151135Cosgrave C, Abbas S, Alexander S. Large bleeding duodenal lipoma. Gastrointest Endosc. 2024 Jul;100(1):153-155. doi: 10.1016/j.gie.2023.12.030. Epub 2023 Dec 25. No abstract available.
- Background: PubMed 35952693Yee EJ, Stewart CL, Clay MR, McCarter MM. Lipoma and Its Doppelganger: The Atypical Lipomatous Tumor/Well-Differentiated Liposarcoma. Surg Clin North Am. 2022 Aug;102(4):637-656. doi: 10.1016/j.suc.2022.04.006.
- 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.
Yukun Luo, Doctor principal investigator
Chinese PLA General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing CUSA Minimally Invasive Resection in people with Lipoma, run by Chinese PLA General Hospital.
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 9 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: opening soon, as of the sponsor's last update on 1 Sep 2026. 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?
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?
Contact Yukun Luo, Doctor (133 1137 3556 ext. 010-66937394, lyk301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete resection rate of lipoma (time frame: Within 1 week after surgery). 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 NCT07797270, which also lists 5 linked publications.
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 1 Sep 2026.