Clinical Trials in China / NCT07113340
Active, not recruiting
Not applicable
Carina™ Surgical Platform for Minimal Radical Gastrectomy
NCT07113340 · tracked via the Priya Life Science China tracker
Condition(s) studied
Robotic GastrectomyStomach Neoplasms
Investigational drug(s) / intervention(s)
Carina™ Surgical Platform, developed by Ronovo Surgical, Inc
Carina™ Surgical Platform, developed by Ronovo Surgical, Inc: A modular surgical robot that offers greater flexibility in the number of instrument arms and surgical layout options.
Study summary
To evaluate the safety and effectiveness of the laparoscopic surgical system（Carina™ Surgical Platform, developed by Ronovo Surgical, Inc) for use in gastrectomy.
Eligibility
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
- Incidence of Serious Complications — 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 — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| the Affiliated Hospital of QIngdao University | Qingdao | Shandong |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07113340 on ClinicalTrials.gov ↗ ← All trials in China