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A prospective, multicenter, single-blind, randomized, parallel-controlled superiority clinical trial evaluating the efficacy and safety of the disposable endoluminal closed lens cleaning puncture device for lens cleaning during laparoscopic surgery

A prospective, multicenter, single-blind, randomized, parallel-controlled superiority clinical trial evaluating the efficacy and safety of the disposable endoluminal closed lens cleaning puncture device for lens cleaning during laparoscopic surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106050
Enrollment
Unknown
Registered
2025-07-16
Start date
2022-10-18
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Surgical laparoscopic operation

Interventions

Experimental Group:The puncture apparatus was cleaned using a single-use intracavinal closed lens
Control group:Conventional lens cleaning method (warm saline containing iodophor and then wipe the gauze)

Sponsors

Zhejiang Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Male or female aged = 18 and = 75; 2.Elective surgery patients who need to perform laparoscopic surgery clinically; 3.Patient without serious systemic diseases; 4.Patients who have good compliance, and can cooperate to complete the whole clinical trial; 5.Patients who shall voluntarily participate in this study, and sign the informed consent form before the study begins.

Exclusion criteria

Exclusion criteria: 1.Patients with local or systemic infection; 2.Patients whose coagulation function is abnormal and cannot be corrected; 3.Patients who are allergic to stainless steel materials; 4.Patients with abdominal wall hernia and diaphragmatic hernia; 5.Patients with severe abdominal and pelvic adhesions or diffuse peritonitis; 6.Surgical space of the patient is limited by the huge tumor in abdominal cavity and pelvic cavity; 7.Female subjects who are pregnant or lactating, or intend to become pregnant; 8.Patients who cannot tolerate surgery; 9.Patients with expected poor compliance; 10.Participated in clinical study of other drugs, biological agents or devices within 3 months; 11.Mentally incapacitated or unable to understand the requirements for participation in the study; 12.Other conditions considered inappropriate by the investigator.

Design outcomes

Primary

MeasureTime frame
Average lens cleaning time;

Secondary

MeasureTime frame
Success rate of puncture;Puncture time;Satisfaction with the operation of the puncture device;Lens cleaning image quality score of the field of view;The freedom of movement of laparoscopic instruments;Operation time;Lens cleaning frequency;The rate of secondary contamination of the lens;Average protection time after coating application; Vital signs;Laboratory examination;Adverse events, serious adverse events and device defects;

Countries

China

Contacts

Public ContactZhang Chengwu

Zhejiang Provincial People's Hospital

zcw1989@sina.com+86 136 0670 4804

Outcome results

None listed

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