Thoracic SurgeryNCT07255703
Thoracic Surgery by SHURUI Single-Port Surgical Robot
An observational study of Thoracic Surgery, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The introduction of single-port surgical robot has been a transformative breakthrough in the medical field, representing a significant advancement in minimally invasive procedures. One notable innovation is the SHURUI single-port surgical robot (SP), developed by Beijing Surgerii Robotics Company Limited. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- Device: Endoscopic Surgical System, SR-ENS-600
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2026to 30 Nov 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing Lobectomy, Segmentectomy, Wedge Resection of the lung, or Mediastinal Tumour Resection.
Who may be able to join
- Age between 18 - 75 years;
- 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;
- Preoperative ASA grade: Grade I-III;
- Subject voluntarily participates in the clinical trial, and agrees or his/her guardian agrees and signs the informed consent.
Who cannot join
- Subjects with a previous history of thoracic surgery or other malignant tumor which, in the judgement of the investigator, make them unsuitable for enrolment;
- Subjects with severe co-morbidities or organ dysfunction (heart, lung, liver, brain, kidney, etc.) or deemed too weak/ unsuitable for general anesthesia or operation;
- Non-correctable coagulopathy and severe bleeding tendency；
- Emergency surgery;
- Severe obesity with BMI ≥30 kg/m2;
- Subjects with severe allergic constitution, suspected or confirmed alcohol, drug addiction;
- Other circumstances in which the investigator considered participation in this clinical trial inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin
Calvin Sze Hang Ng, +852 3505 2618, calvinng@surgery.cuhk.edu.hk
Ng, calvinng@surgery.cuhk.edu.hk
About this study
Official title: Thoracic Surgery by SHURUI Single-Port Surgical Robot: A Prospective Single Centre Study
The introduction of single-port surgical robot has been a transformative breakthrough in the medical field, representing a significant advancement in minimally invasive procedures. One notable innovation is the SHURUI single-port surgical robot (SP), developed by Beijing Surgerii Robotics Company Limited. The SHURUI SP represents a cutting-edge technology in the field. This system features snake-like surgical instruments utilizing "dual continuum mechanism", which enables precise single-port procedures with wide range of motion and high load capacity.
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.
Read more
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, investigators 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, investigators evaluate the early surgical outcome and objective functional outcome of patients undergoing robotic thoracic surgery by SHURUI SP.
- Conditions
- Thoracic Surgery
- Being tested
- Device: Endoscopic Surgical System, SR-ENS-600
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Endoscopic Surgical System, SR-ENS-600Device
undergoing robotic thoracic surgery by the Endoscopic Surgical System, SR-ENS-600
| Study group | Role | What they receive |
|---|---|---|
| Lobectomy, Segmentectomy Wedge resection of lung | Not described Receives: Device: Device: Endoscopic Surgical System, SR-ENS-600 | |
| Mediastinal Tumour Resection | Not described Receives: Device: Device: Endoscopic Surgical System, SR-ENS-600 |
What is being measured
The primary outcome is the main question the study is designed to answer.
conversion rate
The feasibility of the Endoscopic Surgical System, SR-ENS-600 for thoracic robotic procedures (Lobectomy, Segmentectomy Wedge resection of lung and Mediastinal Tumour Resection), as measured by the conversion rate
Measured: 1 year + 1 month follow-up
major peri-operative complication rate (Clavein-Dindo grading III or above)
The safety profile of the Endoscopic Surgical System, SR-ENS-600 for thoracic robotic procedures (Lobectomy, Segmentectomy Wedge resection of lung and Mediastinal Tumour Resection), as measured by the peri-operative complication profile.
Measured: 1 year + 1 month follow-up
Secondary outcomes (11)
Operation time
The time from the beginning of the teleoperation to the ending of the teleoperation. Note: 1) the time of starting the skin incision, 2) the time of the surgical trolley parking, 3) the time of the positioning connection, 4) the time of starting teleoperation, 5) the time of finishing teleoperation, 6) the time of the closing skin incision.
The operation-related time can reflect the maneuverability and ease of use of the instrument. Because the time of equipment preparation, skin incision, positioning connection and so on are interfered by many factors in the operating room, and the time from the beginning of teleoperation to the end of teleoperation is relatively stable, therefore, it is more objective to collect and analyze this period of time.
Measured: 1 year
Estimated intraoperative blood loss (EBL)
Amount of intraoperative blood loss is recorded from the beginning to the end of the surgery
Measured: 1 year
Length of hospital stay
Total length of stay from the day of surgery to discharge. For subjects admitted in the afternoon/ discharged in the morning, 0.5 days were recorded on the day of admission/discharge.
Measured: 1 year + 1 month follow-up
Postoperative pain score
time window: 24 ± 4 hours after surgery, 72 ± 4 hours after surgery, 120 ± 4 hours after surgery. This was assessed using the numerical rating scale (NRS) . The NRS score is clear and objective, which can help subjects make more accurate assessments and improve the comparability of assessments between different subjects. It was once considered the gold standard for pain assessment by the American Society of Pain[11]. This investigation used NRS versions 0-10, the most commonly used NRS (Figure. 5-1) . The subjects were assigned to 4 categories with 11 scores (0-10) : No Pain (0) , mild pain (1-3) , moderate pain (4-6) , and severe pain (7-10) . If the subject is discharged before a certain evaluation time point, the evaluation at that time point and after can not be carried out.
Measured: 1 year + 1 month follow-up
Blood transfusion rate
Proportion of subjects who underwent an intraoperative blood transfusion.
Measured: 1 year
The Surgeon Satisfaction Questionnaire
time window: day 0 ~ within 24 hours after surgery. The Surgeon Satisfaction Questionnaire consists of two parts: the system (the"System" in this questionnaire refers to the investigational device "Endoscopic surgical system") performance-related (items 1 to 12, total of 12) and the surgeon comfort-related score (items 13 to 20, total of 8) . The Rating Scale: 5 points for each question, 1-5 points from top to bottom, full score of 100 points.
Measured: 1 year+ 1 month follow-up
Perioperative complication
Surgical complication rates [ time window: within 30 ± 7 days after surgery] Possible intraoperative complications include thoracic adhesion, intraoperative bleeding, airway injury, and nerve injury. Possible postoperative complications include: pulmonary complications (including persistent air leak, pneumonia, atelectasis, pleural effusion, respiratory insufficiency/respiratory failure, etc.) , recurrent laryngeal nerve paralysis, chylothorax, etc.
Measured: 1 year
device defects incidence
Incidence of device defects time window: the day of surgery. Device defect refers to the unreasonable risks that may endanger human health and safety, such as wrong label, quality problem, malfunction, etc.
Measured: 1 year
readmission rate within 30 days after surgery
for operations other than segmentectomy/lobectomy reasons, not counted as reoperation rate
Measured: 1 month follow-up
re-operation rate with 30 days after surgery
for reasons other than segmentectomy/lobectomy, not counted as the rate of reoperation
Measured: 1 month follow-up
Mortality within 30 days after surgery
Mortality within 30 days after surgery
Measured: 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start1 Aug 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Calvin Sze Hang Ng, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255703
- Sponsor's protocol ID
- KF-600-3-583
- Status last verified
- Oct 2026
- First submitted
- 20 Nov 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will need further discussion