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Clinical research on the safety and efficacy of the thoracoabdominal endoscopic surgical system for thyroid and breast endoscopic surgery

Clinical research on the safety and efficacy of the thoracoabdominal endoscopic surgical system for thyroid and breast endoscopic surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101419
Enrollment
Unknown
Registered
2025-04-24
Start date
2025-04-24
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid lesions

Interventions

Experiment group:Complete the surgery with the assistance of the experimental equipment.

Sponsors

Yantai Yuhuangding Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age range: 18 years old and above, 80 years old and below, Gender: No restrictions; 2.Plan to use the thoraco-abdominal endoscopic surgery system to assist laparoscopic surgery in the thoracic and abdominal cavities. 3.Agree to participate in this research and voluntarily sign the informed consent form. 4.Willing to cooperate in completing the research follow-up and related examinations.

Exclusion criteria

Exclusion criteria: 1.BMI less than 18.5 kg/m^2 or BMI greater than or equal to 30 kg/m^2; 2.Patients with severe cardiovascular diseases who cannot tolerate laparoscopic surgery; 3.Patients with severe respiratory diseases who cannot tolerate laparoscopic surgery; 4.Patients with severe coagulation dysfunction and inability to tolerate laparoscopic surgery; 5.Patients with a history of neck or chest surgeries or radiotherapy and chemotherapy are not suitable for laparoscopic surgery. 6.Pregnant and lactating women; 7.Patients who are currently participating in other clinical trials of drugs or medical devices; 8.The researchers believe that patients who are not suitable for participating in this trial;.

Design outcomes

Primary

MeasureTime frame
Incidence of severe complications;The rate of non-midterm surgery transfer;

Secondary

MeasureTime frame
Pain score;Blood loss during operation (ml);Defect of the equipment;Evaluation of the physiological load during the operation by the chief surgeon;Postoperative mortality rate;The occurrence situations of adverse events and serious adverse events related to the equipment;The incidence of postoperative complications;Evaluation of Instrument Performance;The incidence rate of serious system failures;The rate of system recoverable failure occurrences;Intraoperative blood transfusion rate;Incidence of adverse events and serious adverse events;Evaluation of the mental workload of the chief surgeon during the operation;System preparation time (min);Time (min) for robot-assisted surgery;The incidence of reoperation after surgery;The rate of re-admission after surgery;Postoperative hospital stay (days);

Countries

China

Contacts

Public ContactHaitao Zheng

Yantai Yuhuangding Hospital

zhenghaitao1972@126.com+86 13615351236

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026