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A prospective clinical study on the safety and effectiveness of SHURUI endoscopic surgery system (SR-ENS-600) for thoracic surgery

A prospective clinical study on the safety and effectiveness of SHURUI endoscopic surgery system (SR-ENS-600) for thoracic surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072340
Enrollment
Unknown
Registered
2023-06-09
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

Various diseases of general thoracic surgery

Interventions

Operation group:Robotic surgery

Sponsors

Shanghai Pulmonary Hospital affiliated to Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1)18 years old = actual age =80 years old. 2)Thoracic robotic surgery is required and one of the following surgical indications is indicated: (1)Lobectomy or sleeve lobectomy; (2)Sub-lobectomy; (3)Resection of mediastinal mass. 3)Those who is willing to cooperate and complete the study follow-up and related examinations. 4)Those who is willing to take part in the experiment voluntarily and sign the informed consent in writing.

Exclusion criteria

Exclusion criteria: 1)Those who need emergency surgery. 2)Pregnant or lactating women. 3)Severe cardiovascular or circulatory diseases and cannot tolerate surgery. 4)Participated in clinical trials of other investigational drugs or devices within the past 3 months. 5)Subjects with a history of mental illness. 6)Unable to understand the trial requirements or complete the follow-up plan. 7)Those who was considered inappropriate to participate in this clinical trial by researchers.

Design outcomes

Primary

MeasureTime frame
Success rate of operation;Adverse events;Device defect;

Secondary

MeasureTime frame
Operation Time;The amount of blood loss during the operation;Chest drainage time;Length of hospital stay after operation;Satisfaction rating;

Countries

China

Contacts

Public ContactZhu Yuming

Shanghai Pulmonary Hospital affiliated to Tongji University

ymzhu2005@aliyun.com+86 130 0326 9312

Outcome results

None listed

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