Robotic GastrectomyNCT07113340
Carina™ Surgical Platform for Minimal Radical Gastrectomy
A study testing Carina™ Surgical Platform, developed by Ronovo Surgical, Inc in people with Robotic Gastrectomy and Stomach Neoplasms, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
To evaluate the safety and effectiveness of the laparoscopic surgical system（Carina™ Surgical Platform, developed by Ronovo Surgical, Inc) for use in gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Robotic Gastrectomy, Stomach Neoplasms
- What is being tested?
- Carina™ Surgical Platform, developed by Ronovo Surgical, Inc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 31 Dec 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years, any gender
- Patients with gastric cancer planned to undergo laparoscopic surgery assisted by the laparoscopic surgical system
- Agree to participate in this study and voluntarily sign the informed consent form
- Willing to cooperate with study follow-up and related examinations
Who cannot join
- BMI < 18.5 kg/m² or BMI ≥ 30 kg/m²
- Patients with severe cardiovascular diseases who cannot tolerate laparoscopic surgery
- Patients with severe respiratory diseases who cannot tolerate laparoscopic surgery
- Patients with severe coagulation disorders who cannot tolerate laparoscopic surgery
- Patients with a history of abdominal or pelvic surgery, radiotherapy, or chemotherapy who are not suitable for laparoscopic surgery
- Pregnant or breastfeeding women
- Patients currently participating in other drug or medical device clinical trials
- Patients deemed unsuitable for participation in this study by the investigator
Trial locations and contacts
1 site in 1 country.
China1 site
the Affiliated Hospital of QIngdao University
Qingdao, Shandong, 266000
About this study
Official title: Carina™ Platform - A Single-arm Study for Gastrectomy
To evaluate the safety and effectiveness of the laparoscopic surgical system（Carina™ Surgical Platform, developed by Ronovo Surgical, Inc) for use in gastrectomy.
Read the detailed description
Source data verification: Cross-check between paper and electronic case report forms.
Standard Operating Procedures: The investigator is responsible for patient recruitment, while a independent statistician handles data collection and management. When source data is modified, changes must be traceable in both the electronic system and paper documents.
Statistical analysis plan: Categorical variables were analyzed using chi-square tests, while ordinal data were assessed using non-parametric tests. Continuous variables were analyzed using independent samples t-tests or non-parametric methods, as appropriate.
Handling of Missing Data: Missing data will be handled according to the classification of each dataset. For the Full Analysis Set (FAS), missing values for primary efficacy and safety endpoints will be imputed using the Worst Observation Carry Forward (WOCF) method, and considered as treatment failure or the occurrence of serious complications. No imputation will be performed for missing values in other datasets or for other secondary/exploratory endpoints.
- Conditions
- Robotic Gastrectomy, Stomach Neoplasms
- Being tested
- Carina™ Surgical Platform, developed by Ronovo Surgical, Inc
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carina™ Surgical Platform, developed by Ronovo Surgical, IncDevice
A modular surgical robot that offers greater flexibility in the number of instrument arms and surgical layout options.
| Study group | Role | What they receive |
|---|---|---|
| robot group | Experimental | Carina™ Surgical Platform, developed by Ronovo Surgical, Inc Receives: Device: Carina™ Surgical Platform, developed by Ronovo Surgical, Inc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Serious Complications
Any deviation from the expected postoperative recovery was considered an adverse event and was classified according to the Clavien-Dindo complication grading system. Only complications of grade III or above were included in the analysis.
Measured: From the beginning of surgery until hospital discharge, up to 16 weeks
Rate of No Surgical Conversion
No intraoperative conversion occurred from the robotic laparoscopic endoscopic surgical system-assisted procedure to another surgical instrument control system, conventional laparoscopy, or open surgery. The laparoscopic endoscopic surgical system is a medical device intended to assist the surgeon in accomplishing predefined surgical tasks. Completion of the remaining surgical procedures via laparoscopy or open surgery after the intended tasks have been performed using the system is not regarded as a conversion.
Measured: From the start of surgery to the end of surgery, up to 5 hours
Secondary outcomes (15)
Instrument Defects
Refers to unreasonable risks to human health or life posed by the surgical instruments used with the laparoscopic endoscopic surgical system during the clinical trial, under conditions of intended use. Such risks may arise from labeling errors, quality defects, malfunctions, or other device-related issues.
Measured: From the start of surgery to the end of surgery
Incidence of Device-Related Adverse Events and Serious Adverse Events
Any deviation from the expected postoperative recovery caused by surgical instruments was considered an adverse event and was classified according to the Clavien-Dindo complication grading system. Only complications of grade III or above were included in the analysis.
Measured: From the beginning of surgery until hospital discharge, up to 16 weeks
Postoperative Mortality Rate
Postoperative death is defined as death resulting from causes directly related to the current surgical intervention.
Measured: Perioperative
Incidence of Postoperative Complications
Any adverse event representing a deviation from the expected postoperative recovery was assessed and classified using the Clavien-Dindo complication grading system.
Measured: From the beginning of surgery until hospital discharge, up to 16 weeks
Pain Score
Pain was assessed using the revised Wong-Baker FACES Pain Rating Scale, with scores ranging from 0 (no pain) to 10 (worst possible pain), indicating increasing severity.
Measured: Pain assessments were performed twice: once at 24 hours after surgery and once prior to hospital discharge.
Intraoperative Physiological Load Assessment of the Surgeon
Regional assessments were performed, covering the following areas: four fingers (excluding the thumb) of both hands, bilateral thumbs, bilateral dorsum of hands, wrists, forearms, upper arms, as well as the neck and back. Each region was scored on a scale from 0 to 10, with 0 indicating no discomfort and 10 indicating extreme discomfort in that specific area. Refer to: Lukasz F, Christopher S, Adrian Z, et al. Robot-assisted single-site compared with laparoscopic single-incision cholecystectomy for benign gallbladder disease: protocol for a randomized controlled trial[J]. BMC Surg. 2017 Feb 9;17(1):13.
Measured: An assessment was conducted immediately upon completion of the surgical procedure.
Incidence of System Repairable Failures
A System Repairable Failures is defined as a malfunction occurring during robot-assisted surgery that can be resolved within a short period (within 1 hour) without causing significant disruption to the surgical workflow or alteration of the surgical procedure.
Measured: An assessment was conducted immediately upon completion of the surgical procedure.
Postoperative Length of Hospital Stay
Postoperative length of hospital stay was calculated as the number of days between the date of surgery and the date of discharge.
Measured: Perioperative
Robot-Assisted Surgery Time
Robot-assisted operative time was defined as the duration from the moment the surgeon initiated control of the surgical instruments to the moment the first robotic arm of the laparoscopic endoscopic surgical system was disengaged from the trocar and instrument control was concluded.
Measured: During surgery
Intraoperative Transfusion Rate
The proportion of participants who underwent blood transfusion during the surgical procedure.
Measured: During surgery
Intraoperative Mental Workload Assessment of the Surgeon
According to "Subjective Mental Effort Questionnaire". Refer to "van der Schatte Olivier RH, Van't Hullenaar CD, Ruurda JP, Broeders IA. Ergonomics, user comfort, and performance in standard and robot-assisted laparoscopic surgery. Surg Endosc. 2009;23(6):1365-1371. doi: 10.1007/s00464-008-0184-6." 0 is "no effort at all" and 150 is "exceptional amount of effort; "
Measured: An assessment was conducted immediately upon completion of the surgical procedure.
Intraoperative Blood Loss
Blood loss was estimated using visual assessment, measurement via vacuum suction devices, or by weighing blood-soaked gauze.
Measured: During surgery
System Setup Time
System preparation time was defined as the interval between the moment the first robotic arm of the laparoscopic endoscopic surgical system was docked to the trocar and the moment the surgeon gained control of the instruments to initiate the procedure.
System preparation time was defined as the interval between the moment the first robotic arm of the laparoscopic endoscopic surgical system was docked to the trocar and the moment the surgeon gained control of the instruments to initiate the procedure.
System preparation time was defined as the interval between the moment the first robotic arm of the laparoscopic endoscopic surgical system was docked to the trocar and the moment the surgeon gained control of the instruments to initiate the procedure.
Measured: During surgery
Incidence of System Serious Failures
A serious system failure is defined as a malfunction occurring during robot-assisted surgery that either cannot be resolved within a short period (within 1 hour), or has a substantial impact on the surgical procedure or intraoperative workflow.
Measured: During surgery
Instrument Performance Evaluation
The laparoscopic camera system and intraoperative surgical instruments-including the ultrasonic scalpel, electrosurgical scissors, needle holder, and grasping forceps-were evaluated on a four-grade scale: excellent, good, fair, and poor. Evaluation parameters included clarity of the surgical field, 3D visual fatigue, instrument stability, response latency, and operational flexibility.
Measured: An assessment was conducted immediately upon completion of the surgical procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 May 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic GastrectomyStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao 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
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhouyanbing, The Affiliated Hospital of Qingdao University
- Investigators
- Yanbing Zhou, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113340
- Sponsor's protocol ID
- China-made surgical robot 01
- Status last verified
- Aug 2025
- First submitted
- 14 Jun 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Investigators will not share IPD unless contact the study responsible party and obtain consent.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carina™ Platform - A Single-arm Study for Gastrectomy
- ClinicalTrials.gov ID
- NCT07113340
- Acronym / sponsor ID
- China-made surgical robot 01
- Conditions
- Robotic Gastrectomy, Stomach Neoplasms
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Aug 2025 (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.
To evaluate the safety and effectiveness of the laparoscopic surgical system（Carina™ Surgical Platform, developed by Ronovo Surgical, Inc) for use in gastrectomy.
Detailed description
Source data verification: Cross-check between paper and electronic case report forms.
Standard Operating Procedures: The investigator is responsible for patient recruitment, while a independent statistician handles data collection and management. When source data is modified, changes must be traceable in both the electronic system and paper documents.
Statistical analysis plan: Categorical variables were analyzed using chi-square tests, while ordinal data were assessed using non-parametric tests. Continuous variables were analyzed using independent samples t-tests or non-parametric methods, as appropriate.
Handling of Missing Data: Missing data will be handled according to the classification of each dataset. For the Full Analysis Set (FAS), missing values for primary efficacy and safety endpoints will be imputed using the Worst Observation Carry Forward (WOCF) method, and considered as treatment failure or the occurrence of serious complications. No imputation will be performed for missing values in other datasets or for other secondary/exploratory endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| robot group | Experimental | Device: Carina™ Surgical Platform, developed by Ronovo Surgical, IncCarina™ Surgical Platform, developed by Ronovo Surgical, Inc |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 80 years, any gender
- Patients with gastric cancer planned to undergo laparoscopic surgery assisted by the laparoscopic surgical system
- Agree to participate in this study and voluntarily sign the informed consent form
- Willing to cooperate with study follow-up and related examinations
Key exclusion criteria (8 listed)
- BMI < 18.5 kg/m² or BMI ≥ 30 kg/m²
- Patients with severe cardiovascular diseases who cannot tolerate laparoscopic surgery
- Patients with severe respiratory diseases who cannot tolerate laparoscopic surgery
- Patients with severe coagulation disorders who cannot tolerate laparoscopic surgery
- Patients with a history of abdominal or pelvic surgery, radiotherapy, or chemotherapy who are not suitable for laparoscopic surgery
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 |
|---|---|---|
| Carina™ Surgical Platform, developed by Ronovo Surgical, IncA modular surgical robot that offers greater flexibility in the number of instrument arms and surgical layout options. | Device | robot group |
Primary outcome
Incidence of Serious Complications
Time frame: From the beginning of surgery until hospital discharge, up to 16 weeks
Any deviation from the expected postoperative recovery was considered an adverse event and was classified according to the Clavien-Dindo complication grading system. Only complications of grade III or above were included in the analysis.
Rate of No Surgical Conversion
Time frame: From the start of surgery to the end of surgery, up to 5 hours
No intraoperative conversion occurred from the robotic laparoscopic endoscopic surgical system-assisted procedure to another surgical instrument control system, conventional laparoscopy, or open surgery. The laparoscopic endoscopic surgical system is a medical device intended to assist the surgeon in accomplishing predefined surgical tasks. Completion of the remaining surgical procedures via laparoscopy or open surgery after the intended tasks have been performed using the system is not regarded as a conversion.
15 secondary outcomes
Instrument Defects
Time frame: From the start of surgery to the end of surgery
Incidence of Device-Related Adverse Events and Serious Adverse Events
Time frame: From the beginning of surgery until hospital discharge, up to 16 weeks
Postoperative Mortality Rate
Time frame: Perioperative
Incidence of Postoperative Complications
Time frame: From the beginning of surgery until hospital discharge, up to 16 weeks
Pain Score
Time frame: Pain assessments were performed twice: once at 24 hours after surgery and once prior to hospital discharge.
Intraoperative Physiological Load Assessment of the Surgeon
Time frame: An assessment was conducted immediately upon completion of the surgical procedure.
Incidence of System Repairable Failures
Time frame: An assessment was conducted immediately upon completion of the surgical procedure.
Postoperative Length of Hospital Stay
Time frame: Perioperative
Robot-Assisted Surgery Time
Time frame: During surgery
Intraoperative Transfusion Rate
Time frame: During surgery
Intraoperative Mental Workload Assessment of the Surgeon
Time frame: An assessment was conducted immediately upon completion of the surgical procedure.
Intraoperative Blood Loss
Time frame: During surgery
System Setup Time
Time frame: During surgery
Incidence of System Serious Failures
Time frame: During surgery
Instrument Performance Evaluation
Time frame: An assessment was conducted immediately upon completion of the surgical procedure.
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 8 Aug 2025.
- Individual participant dataSharing planned: No. Investigators will not share IPD unless contact the study responsible party and obtain consent.
Related trials for Robotic Gastrectomy
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HUGO-SLEEVE: Evaluating the Feasibility of Robotic Sleeve Gastrectomy With a New Platform
Obesity (BMI > 35), Obesity (BMI > 35) and Diabetes Mellitus
Not yet recruiting
Safety and Efficacy Evaluation of Single-Port Versus Multi-Port Robotic-Assisted Radical Distal Gastrectomy for Gastric Cancer
STOMACH NEOPLASM, Robotic Surgical Procedures
RecruitingObservational study
The Safety and Efficacy of Robotic Assisted Surgery Using Vessel Sealer Extend in Locally Advanced Gastric Cancer
Locally Advanced Gastric Cancer, Gastric Adenocarcinoma
Active, not recruitingPhase 2
Maxigesic for Postoperative Pain Control After Laparoscopic or Robotic Gastrectomy
Stomach Neoplasms
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. This study is not recruiting at the moment.
Yanbing Zhou principal investigator
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carina™ Surgical Platform, developed by Ronovo Surgical, Inc in people with Robotic Gastrectomy and Stomach Neoplasms, run by The Affiliated Hospital of Qingdao 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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 8 Aug 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Serious Complications (time frame: From the beginning of surgery until hospital discharge, up to 16 weeks). 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 8 Aug 2025.