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Clinical Evaluation of a Single-Use Sterile Drainage Catheter (Model A): A Prospective Study on Safety and Efficacy

Clinical Evaluation of a Single-Use Sterile Drainage Catheter (Model A): A Prospective Study on Safety and Efficacy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107023
Enrollment
Unknown
Registered
2025-08-01
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

None

Interventions

Experimental group:Intervention Name: Disposable Sterile Drainage Tube (Type A) Model Specification: Type A Manufacturer: Shandong Weigao Group Medical Polymer Products Co., Ltd. Usage: Intraoperative

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Subjects who need to undergo laparoscopic surgery; 2. 18 years old< = age< = 80 years old; 3. Subjects who sign the informed consent form and can cooperate with the entire trial process.

Exclusion criteria

Exclusion criteria: 1.Patients with coagulation dysfunction; 2.Any other condition deemed ineligible by the investigator;

Design outcomes

Primary

MeasureTime frame
Smoke Evacuation Success Rate;

Secondary

MeasureTime frame
Compatibility Success Rate with Negative Pressure Devices;Secure Connection Rate with the Laparoscope;Proportion of Optimal Visualization Time;Incidence Rate of Intraoperative Infections;Incidence of Other Adverse Events;Smoke Evacuation Efficiency;Intraoperative Air-tightness Rate;

Countries

China

Contacts

Public ContactXiaoping Zhu

Shanghai Tenth People's Hospital

juliya1107@163.com+86 21 6630 1604

Outcome results

None listed

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