Lung CancerNCT06286150
Efficacy and Safety of Single-port Surgical Robot System in Thoraic Surgery
A study testing Surgical robot system in people with Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
Robotic surgical systems have become a promising surgical assistance system, with unique advantages such as 3D high-definition visual system, highly flexible wrist-jointed instruments, and automatic fitering of hand tremors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Surgical robot system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2023to 15 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age between 18 and 75 years, regardless of gender.
- Patients who require endoscopic surgical treatment and have indications for lung segment/lobe resection; for pre-trial subjects, there is no restriction on the type of procedure, and inclusion is based on the investigator's judgment of having indications for thoracic surgery.
- Preoperative ASA classification of I-III.
- Voluntary participation in the clinical trial and willingness to provide informed.
- consent, either by the subject or their guardian.
- Willingness to cooperate and complete trial follow-up and related examinations.
Who cannot join
- Patients with a history of thoracic surgery or previous history of other malignant tumors deemed unsuitable for inclusion by the investigator.
- Patients with severe comorbidities (cardiac, pulmonary, hepatic, cerebral, renal diseases) or physical weakness who cannot tolerate general anesthesia or surgery.
- Patients with severe bleeding tendencies or coagulation disorders.
- Patients in the active phase of infectious diseases or with other severe non-communicable infections.
- Patients positive for Human Immunodeficiency Virus (HIV) antibodies or syphilis seropositive patients.
- Patients with a suspected or confirmed alcohol, drug, or substance addiction.
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- Patients with a history of epilepsy, mental illness, or cognitive impairment.
- Women who are pregnant, breastfeeding, or planning to become pregnant during the trial period.
- Participation in other interventional clinical trials within 3 months prior to signing the informed consent form.
- Other situations in which the investigator deems inappropriate for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Jianxing He, M.D., +86-20-83337792, hejx@vip.163.com
About this study
Official title: Efficacy and Safety of Single-port Surgical Robot System in Thoraic Surgery: A Prospective, Single Center Study
Robotic surgical systems have become a promising surgical assistance system, with unique advantages such as 3D high-definition visual system, highly flexible wrist-jointed instruments, and automatic fitering of hand tremors. Robotic surgical systems is applied in various fields including urology, general surgery, cardiothoracic surgery, head and neck surgery, and gynecology. Currently, the Da Vinci surgical robot system is the most widely used robot system globally. However, the Da Vinci robot system for single-port laparoscopic surgery has not yet been launched in China. Therefore, the investigators conduct a prespective, single-center study to evaluate the efficacy and safety of single-port surgical robot system in thoracic surgery.
- Conditions
- Lung Cancer
- Being tested
- Surgical robot system
- Keywords
- surgical robot system, efficacy, safety, thoracic surgery
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical robot systemProcedure or surgery
SHURUI Single-port surgical robot system
| Study group | Role | What they receive |
|---|---|---|
| single-port robot group | Experimental | Not described Receives: Procedure: Surgical robot system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative conversion rate
The conversion from a single-port laparoscopic surgery system to other surgical Instrument control systems, such as traditional thoracoscopy or open surgery.
Measured: Within 1 day after surgery
Surgical complications rate
The incidence rate of instrument-related or potentially instrument-related surgical complications meeting Clavien-Dindo grade 3 or above criteria from the time of incision
Measured: 30 days after surgery
Secondary outcomes (9)
Intraoperating bleeding volume
The amount of intraoperative bleeding from the start to the end of the surgery in the study subjects
Measured: Within 1 day after surgery
Surgical time
Measured: Within 1 day after surgery
Length of hospital admissions
The total number of days of hospitalization from the day of surgery to discharge for the study subjects.
If a subject is admitted in the afternoon or discharged in the morning, the day of admission or discharge is recorded as 0.5 days.
Measured: Within 30 day after surgery
Postoperative wound pain score
Assessment will be conducted using the Numerical Rating Scale (NRS)
Measured: 1, 24 and 72 hours after surgery
Surgeon satisfaction
The surgeon satisfaction survey questionnaire consists of two parts: performance-related (12 questions) and surgeon comfort-related ratings (8 questions). The scoring criteria are as follows: Each question is scored on a scale of 1-5, with a maximum score of 5. The total score is out of 100
Measured: Within 4 hours after surgery
Adverse events
Incidence of adverse events (AE), serious adverse events (SAE), and overall surgical complication rate (evaluated using the Clavien-Dindo grading system)
Measured: Within 1 day after surgery
Rate of re-admission to hospital
Measured: 30 days after discharge
Rate of reoperation
Measured: 30 days after surgery
Postoperative mortality
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start15 Sep 2023
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286150
- Sponsor's protocol ID
- EC-2023-087(QX)-03
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Single-port Surgical Robot System in Thoraic Surgery: A Prospective, Single Center Study
- ClinicalTrials.gov ID
- NCT06286150
- Acronym / sponsor ID
- EC-2023-087(QX)-03
- Conditions
- Lung Cancer
- Keywords
- surgical robot system, efficacy, safety, thoracic surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Robotic surgical systems have become a promising surgical assistance system, with unique advantages such as 3D high-definition visual system, highly flexible wrist-jointed instruments, and automatic fitering of hand tremors. Robotic surgical systems is applied in various fields including urology, general surgery, cardiothoracic surgery, head and neck surgery, and gynecology. Currently, the Da Vinci surgical robot system is the most widely used robot system globally. However, the Da Vinci robot system for single-port laparoscopic surgery has not yet been launched in China. Therefore, the investigators conduct a prespective, single-center study to evaluate the efficacy and safety of single-port surgical robot system in thoracic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-port robot group | Experimental | Procedure: Surgical robot system |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 75 years, regardless of gender.
- Patients who require endoscopic surgical treatment and have indications for lung segment/lobe resection; for pre-trial subjects, there is no restriction on the type of procedure, and inclusion is based on the investigator's judgment of having indications for thoracic surgery.
- Preoperative ASA classification of I-III.
- Voluntary participation in the clinical trial and willingness to provide informed.
- consent, either by the subject or their guardian.
Key exclusion criteria (10 listed)
- Patients with a history of thoracic surgery or previous history of other malignant tumors deemed unsuitable for inclusion by the investigator.
- Patients with severe comorbidities (cardiac, pulmonary, hepatic, cerebral, renal diseases) or physical weakness who cannot tolerate general anesthesia or surgery.
- Patients with severe bleeding tendencies or coagulation disorders.
- Patients in the active phase of infectious diseases or with other severe non-communicable infections.
- Patients positive for Human Immunodeficiency Virus (HIV) antibodies or syphilis seropositive patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical robot systemSHURUI Single-port surgical robot system | Procedure or surgery | single-port robot group |
Primary outcome
Intraoperative conversion rate
Time frame: Within 1 day after surgery
The conversion from a single-port laparoscopic surgery system to other surgical Instrument control systems, such as traditional thoracoscopy or open surgery.
Surgical complications rate
Time frame: 30 days after surgery
The incidence rate of instrument-related or potentially instrument-related surgical complications meeting Clavien-Dindo grade 3 or above criteria from the time of incision
9 secondary outcomes
Intraoperating bleeding volume
Time frame: Within 1 day after surgery
Surgical time
Time frame: Within 1 day after surgery
Length of hospital admissions
Time frame: Within 30 day after surgery
Postoperative wound pain score
Time frame: 1, 24 and 72 hours after surgery
Surgeon satisfaction
Time frame: Within 4 hours after surgery
Adverse events
Time frame: Within 1 day after surgery
Rate of re-admission to hospital
Time frame: 30 days after discharge
Rate of reoperation
Time frame: 30 days after surgery
Postoperative mortality
Time frame: 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical robot system in people with Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianxing He, M.D. (+86-20-83337792, hejx@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative conversion rate (time frame: Within 1 day after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.