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Clinical trials to evaluate the effectiveness and safety of the endoscopic surgical system for urological surgery

Clinical trials to evaluate the effectiveness and safety of the endoscopic surgical system for urological surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048179
Enrollment
Unknown
Registered
2021-07-04
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-03-14

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

Conditions

Urological surgery

Interventions

Experimental group:the endoscopic surgical system for urological surgery

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The age is not less than 18 years old, and the gender is not limited; 2. Those who need to receive urological surgery; 3. Body mass index (BMI): 18.5 ~ 30 kg/m2; 4. Patients whose physical status is graded from grade i to grade iii, according to the classification system of the American Association of Anesthesiologists (ASA) ; 5. Those who are able to cooperate in completing the visits and related inspections specified in the plan; 6. The subject voluntarily participates in the clinical trial, and agrees or is agreed by the guardian to sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who have other malignant tumors or have a history of other malignant tumors in the past; 2. Patients who have received surgical treatment of the urinary system in the past; 3. Those who have undergone other major surgery within 3 months before the enrollment and during the trial period, or who cannot recover from the side effects of any such surgery; 4. Patients with active tuberculosis; 5. Immunodeficiency virus (HIV) antibody positive; hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb) positive, and the copy number of hepatitis B virus DNA (HBV-DNA) is higher than the lower limit of detection or the normal range patients; Hepatitis C virus (HCV) antibody positive patients; Treponema pallidum positive patients; 6. Those who suffer from serious systemic diseases and are deemed unsuitable for surgical treatment by the investigator; 7. Long-term user of anticoagulant and antiplatelet drugs (anti-platelet aggregation drugs are discontinued less than 1 week before surgery), or patients with a history of bleeding disorders or hematopoietic dysfunction or coagulation dysfunction; 8. People with severe allergies and suspected or determined addiction to alcohol, medicines or drugs; 9. Those with a history of epilepsy or mental illness or cognitive impairment; 10. Women who are pregnant, breastfeeding or planning to become pregnant during the trial, and men or women who are unwilling to take barrier contraceptive measures during the trial; 11. Those who have participated in other interventional clinical trials within 3 months before screening; 12. Other situations where the investigator thinks it is inappropriate to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Surgical success rate;

Countries

China

Contacts

Public ContactWang Linhui

Shanghai Changhai Hospital

wanglinhuicz@163.com+86 13901635510

Outcome results

None listed

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