To Evaluate the Effectiveness and Safety of Single-port Robotic-assisted Subcutaneous Gland Resection in Males

A Prospective, Single-center, Single-arm Clinical Study to Evaluate the Effectiveness and Safety of Single-port Robotic-assisted Subcutaneous Gland Resection in Males

The new technology of robotic surgery system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of robotic surgery system in China in the treatment of gynecomastia is still in the exploratory stage and needs to be further improved. This prospective, single-center, single-arm clinical study was conducted to use the single-port robot and evaluate the effectiveness and safety of the subcutaneous gland resection in the treatment of gynecomastia.

Study Overview

• Status: Not yet recruiting
• Conditions: Gynecomastia
• Intervention / Treatment: Procedure: Single-port Robotic-assisted Subcutaneous Gland Resection in males

Detailed Description

The new technology of robotic surgery system, as an emerging technology, has shown certain application prospects in breast surgery. However, the new technology of robotic surgery system in China in the treatment of gynecomastia is still in the exploratory stage and needs to be further improved. This prospective, single-center, single-arm clinical study was conducted to use the single-port robot and evaluate the effectiveness and safety of the subcutaneous gland resection in the treatment of gynecomastia.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qiang Ding, Professor; Phone Number: 13951731373; Email: dingqiang@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the single-port robotic-assisted subcutaneous gland resection group; the single-port robotic-assisted subcutaneous gland resection in the management of gynecomastia	Procedure: Single-port Robotic-assisted Subcutaneous Gland Resection in males; Single-port Robotic-assisted Subcutaneous Gland Resection for males in the treatment of gynecomastia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's and doctor's satisfaction	Use the Health Status Survey Questionnaire (SF-36) to assess the general condition of patients.	2 years
Patient's psychological status using the Self Rating Anxiety Scale (SAS)	Use the Self Rating Anxiety Scale (SAS) to assess the psychological status of patients.	2 years
Patient's psychological status	Use the Self Rating Depression Scale (SDS) to assess the psychological status of patients.	2 years
Patient's sensory	Using Semmes Weinstein (S-W) monofilament to detect postoperative sensory recovery in patients.	2 years

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: January 19, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Single-port Robotic-assisted subcutaneous gland resection
• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Gynecomastia
• Other Study ID Numbers: DQ-GYN-Robot-20251010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No