An interventional study of CUSA Minimally Invasive Resection in Lipoma, sponsored by Chinese PLA General Hospital. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Treatment
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.
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.
22 studies on the registry are indexed under Lipoma; 6 are open to participants now.
This study's planned enrollment of 30 is close to the median of 30 across 17 interventional studies indexed under Lipoma.
Browse Lipoma studies →Chinese PLA General Hospital is the lead sponsor of 570 studies on the registry; 207 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. Aged 18 to 60 years; 2. Subcutaneous lipoma confirmed by ultrasound and needle 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 form; 8. Willing to cooperate with preoperative examinations, intraoperative procedures, and postoperative follow-up.
-
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: CUSA Minimally Invasive Resection
CUSA Minimally Invasive Resection
Complete resection rate of lipoma
Proportion of patients with complete resection of lipoma confirmed by postoperative ultrasound or pathological examination.
Time frame: Within 1 week after surgery
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chinese PLA General Hospital →