Robot scalpel takes on man boobs: new study tests precision surgery
NCT ID NCT07353411
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new robotic surgery to remove excess breast gland tissue in men with gynecomastia (enlarged breasts). Twenty men aged 18-75 who have had breast enlargement for over a year and haven't responded to medication will undergo single-port robotic-assisted surgery. The goal is to see if the procedure is safe and effective, and how it affects patients' satisfaction, anxiety, depression, and sensation after surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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17 to 75 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male patients, aged 18-75 years old; 2. Preoperative breast ultrasound indicates male breast development, and breast enlargement symptoms persist for more than 1 year; 3. Primary male breast development that has been unresponsive to drug treatment, or those who refuse drug treatment; 4. According to Gynecomastia's surgical indications, refer to the "2023 Expert consensus on the clinicaldiagnosis and treatment of gynecomastia in China" Simon grading of male breast development IIb or above; 5. Due to social pressure or severe psychological burden caused by symptoms such as breast pain, those who have a strong desire for surgery may experience psychological burden caused by the disease and actively request surgery; 6. Individuals without serious accompanying diseases; 7. Suspected malignant transformation; 8. No other serious underlying diseases in the past; 9. The surgical procedure includes a single hole robot (intraperitoneal endoscopic single hole surgical system SP1000) for subcutaneous gland resection of the breast; 10. Participants are able to understand the research process, voluntarily join the study, sign informed consent forms, have good compliance, and cooperate with follow-up; 11. No swallowing difficulties; No shoulder joint movement disorders; 12. Complete clinical data. Exclusion Criteria: 1. Age\<16 years old, still in puberty, or disease duration ≤ 1 year; 2. Simple obesity, no obvious glandular tissue was found on breast ultrasound examination; 3. Male patients with breast developmental disorders secondary to other diseases; 4. Patients with contraindications for general anesthesia surgery such as coagulation dysfunction and severe cardiovascular disease, who cannot tolerate surgery; 5. The clinical data is basically incomplete; 6. Other surgical methods; 7. Individuals with a history of breast surgery or breast tumors in the past; 8. The serious diseases of non malignant tumors such as congenital testicular hypoplasia syndrome, cirrhosis, primary hypogonadism, and hyperthyroidism will affect the patient's compliance or put the patient in a dangerous state; 9. Dementia, intellectual disability, or any mental illness that hinders understanding of informed consent forms; 10. Lack of trust in surgical outcomes and weak desire for surgery.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
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A doctor treating you
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