Thoracic Surgery by SHURUI Single-Port Surgical Robot: A Prospective Single Centre Study
NCT ID: NCT07255703
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
40 participants
OBSERVATIONAL
2025-11-20
2026-11-30
Brief Summary
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The SHURUI SP has been cleared by the National Medical Products Administration (NMPA) of China for use in urology and gynecology and has completed clinical trials for general surgery and thoracic surgery. It is China's first and the world's second approved single-port surgical robot. Compared to multi-port surgical robots, it can provide patients with less trauma, fewer complications, and faster recovery.
The SHURUI SP has also achieved significant breakthroughs in clinical applications. It conducted the world's first randomized controlled clinical trial on single-port robotic urologic surgery and introduced a series of innovative surgical paradigms. These include the world's first single-port sleeve lobectomy, single-port retroperitoneal adrenalectomy, single-port retroperitoneal partial nephrectomy, single-port distal gastrectomy (Billroth I anastomosis), and single-port total gastrectomy.
Our centre is the first robotic surgical centre in Hong Kong since 2005. Over the years, we have established our centre to be one of the leading centre in Hong Kong and the region, with involvement in various new development in thoracic robotic procedures, publications and books, and more recently in robotic endo-lumenal procedures.
In this study, we evaluate the early surgical outcome and objective functional outcome of patients undergoing robotic thoracic surgery by SHURUI SP.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Lobectomy, Segmentectomy Wedge resection of lung
Device: Endoscopic Surgical System, SR-ENS-600
undergoing robotic thoracic surgery by the Endoscopic Surgical System, SR-ENS-600
Mediastinal Tumour Resection
Device: Endoscopic Surgical System, SR-ENS-600
undergoing robotic thoracic surgery by the Endoscopic Surgical System, SR-ENS-600
Interventions
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Device: Endoscopic Surgical System, SR-ENS-600
undergoing robotic thoracic surgery by the Endoscopic Surgical System, SR-ENS-600
Eligibility Criteria
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Inclusion Criteria
2. Subjects need to undergo endoscopic surgery and meet one of the following indications for surgical treatment:
* Lobectomy, segmentectomy wedge resection of lung: Clinically diagnosed resectable early stage non-small cell lung carcinoma; oligometastatic cancer to the lung;
* Mediastinal mass resection: Clinically diagnosed mediastinal tumour (benign or malignant) that are indicated for resection;
3. Preoperative ASA grade: Grade I-III;
4. Subject voluntarily participates in the clinical trial, and agrees or his/her guardian agrees and signs the informed consent.
Exclusion Criteria
2. Subjects with severe co-morbidities or organ dysfunction (heart, lung, liver, brain, kidney, etc.) or deemed too weak/ unsuitable for general anesthesia or operation;
3. Non-correctable coagulopathy and severe bleeding tendency；
4. Emergency surgery;
5. Severe obesity with BMI ≥30 kg/m2;
6. Subjects with severe allergic constitution, suspected or confirmed alcohol, drug addiction;
7. Other circumstances in which the investigator considered participation in this clinical trial inappropriate.
18 Years
75 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Calvin Sze Hang Ng
Professor
Locations
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Prince of Wales Hospital
Shatin, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KF-600-3-583
Identifier Type: -
Identifier Source: org_study_id
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