Urological diseases
Conditions
Interventions
Experimental group (Part I: a randomized, single-blind, parallel-controlled study):The experimental group is treated with the laparoscopic endoscopic surgery system (MP1000) produced by Shenzhen Jingf
Control group (Part I: a randomized, single-blind, parallel-controlled study):The control group was treated with the multi-hole robot-assisted surgical system (Da Vinci) developed by Intuitive Surgery
Experimental group (Part II: single-arm clinical study):The experimental group (Part II: single-arm clinical study) is treated with the laparoscopic endoscopic surgery system (MP1000) produced by She
Sponsors
The Third Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) 18-80 years old (inclusive), male or female; 2) BMI:18-30Kg/m2; 3) There are indications for urological surgery; 4) Physiological condition is suitable for laparoscopic surgery; 5) Willing to complete the follow-up and related examinations; 6) Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Have severe or poorly controlled medical disease and cannot tolerate surgery; 2) pregnancy or breastfeeding; 3) Have a history of epilepsy or psychosis; 4) Severe allergies and suspected or confirmed alcohol or drug addiction; 5) There are contraindications to laparoscopic surgery; 6) Participated in other clinical studies within 30 days (except for in vitro diagnostic reagents); 7) The investigator thinks it is unsuitable to participate in this study (such as the subject being unwilling to accept the research plan, unrealistic expectations or obvious emotional problems, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical success rate;Double kidney time-radioactive counting curve; | — |
Secondary
| Measure | Time frame |
|---|---|
| Perioperative complication rate;Change in creatinine concentration;Change in prostate-specific antigen concentration;Installation time (min) [Preoperative preparation time];Operative time (min);Console operation time (min);Intraoperative blood loss (mL);Positive rate of margins;Postoperative pain;Physician satisfaction;Tumor recurrence rate; | — |
Countries
China
Contacts
Public ContactXin Ma
Chinese PLA General Hospital
Outcome results
None listed