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Multi-center, randomized, single-blind, parallel controlled clinical trial to evaluate the safety and effectiveness of the endoscopic surgical instrument control system (MP1000)

Multi-center, randomized, single-blind, parallel controlled clinical trial to evaluate the safety and effectiveness of the endoscopic surgical instrument control system (MP1000)

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045537
Enrollment
Unknown
Registered
2021-04-19
Start date
2021-04-26
Completion date
Unknown
Last updated
2021-11-29

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

Conditions

Urological Disease

Interventions

Experimental group:Endoscopic surgical instrument control system MP1000
Control group:Endoscopic surgical instrument control system IS 3000

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age from 18 to 80 years; 2.BMI: 18-30Kg/m^2; 3.Has the urological surfery indications; 4.Patients with physiological conditions acceptable for laparoscopic surgery; 5.Willing to cooperate and complete the study follow-up and related examinations; 6.Volintary to sign the informed consent.

Exclusion criteria

Exclusion criteria: 1.Have severe cardiovascular or circulatory diseases and cannot tolerate surgery; 2.Conception or lactation; 3.History of epilepsy or mental disease; 4.There is a history of surgery at the relevant surgical site; 5.Severe allergies and suspected or confirmed alcohol or drug addiction; 6.Abdominal infection, peritonitis, diaphragmatic hernia, severe systemic infection or metastatic disease 7.Enrolled in other trails within 90 days; 8.Subjects considered unsuitable for the study by the researcher (e.g., subjects unwilling to accept the study plan, unrealistic expectations, or obvious emotional problems, etc.)

Design outcomes

Primary

MeasureTime frame
Success rate of operation;

Secondary

MeasureTime frame
Perioperative complication rate;Changes in creatinine concentration;Changes in prostate specific antigen concentration;Blood lost;Margin positive rate;Surgeon satisfaction;Postoperative tumor recurrence rate;Installation time (min);Operation time (min);Postoperation pain;

Countries

China

Contacts

Public ContactZhang Xu

Chinese PLA General Hospital

xzhang@foxmail.com+86 13801350955

Outcome results

None listed

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