Carinaâ„¢ Surgical Platform for Minimal Radical Gastrectomy
China20 participantsStarted 2025-05-01
Plain-language summary
To evaluate the safety and effectiveness of the laparoscopic surgical system(Carina™ Surgical Platform, developed by Ronovo Surgical, Inc) for use in gastrectomy.
Who can participate
Age range18 Years – 80 Years
SexALL
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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
What they're measuring
1
Incidence of Serious Complications
Timeframe: From the beginning of surgery until hospital discharge, up to 16 weeks
2
Rate of No Surgical Conversion
Timeframe: From the start of surgery to the end of surgery, up to 5 hours
Trial details
NCT IDNCT07113340
SponsorThe Affiliated Hospital of Qingdao University