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To evaluate the safety and efficacy of laparoscopic surgical system(HLP-560) for thoracic and abdominal endoscopic surgery(General Surgery)

To evaluate the safety and efficacy of laparoscopic surgical system(HLP-560) for thoracic and abdominal endoscopic surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086054
Enrollment
Unknown
Registered
2024-06-24
Start date
2024-06-11
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Patients who plan to undergo laparoscopic surgical system assisted laparoscopic surgery

Interventions

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1)18 years old = age =80 years old, gender is not limited; 2) Patients who plan to undergo laparoscopic surgical system assisted laparoscopic surgery; 3) Agree to participate in this study, and voluntarily sign the informed consent; 4) Willing to cooperate to complete the study follow-up and related examinations.

Exclusion criteria

Exclusion criteria: 1) BMI < 18.5kg/m2 or BMI=30kg/m2; 2) Patients with severe cardiovascular diseases who cannot tolerate laparoscopic thoracic surgery; 3) Patients with severe respiratory diseases who cannot tolerate laparoscopic thoracic surgery; 4) Patients with severe coagulation dysfunction who cannot tolerate laparoscopic thoracic surgery; 5) Patients with a history of thoracic, abdominal and pelvic surgery or chemoradiotherapy are not suitable for thoracic laparoscopic surgery; 6) Pregnant and lactating women; 7) Patients who are participating in clinical trials of other drugs or medical devices; 8) Patients considered unsuitable for this study by the investigators.

Design outcomes

Primary

MeasureTime frame
Non-conversion rate of surgery(efficacy indicator);Serious complication rate of surgery(safety indicator);

Secondary

MeasureTime frame
System preparation time;Robot-assisted surgery time;Device performance evaluation;Intraoperative physiological load evaluation by the surgeon during surgery;Evaluation of the mental load of the surgeon during surgery;Postoperative hospital stay;Pain score(efficacy indicator);Intraoperative blood loss;Intraoperative blood transfusion rate;Incidence of device defect;System repairable failure rate;System serious failure rate;Postoperative complication rate;Postoperative readmission rate;Postoperative reoperation rate;Postoperative mortality;Device-related adverse events and serious adverse events;Adverse events and serious adverse events(safety indicator);

Countries

China

Contacts

Public ContactLi Taiyuan

The First Affiliated Hospital of Nanchang University

jylitaiyuan@sina.com+86 139 7003 1518

Outcome results

None listed

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