Carina™ Surgical Platform for Minimal Radical Gastrectomy

Qingdao University

Status: Active, not recruiting

Conditions: Stomach Neoplasms; Robotic Gastrectomy

Treatments: Device: Carina™ Surgical Platform, developed by Ronovo Surgical, Inc

Study type: Interventional

Funder types: Other

Identifiers

NCT07113340

China-made surgical robot 01

Details and patient eligibility

About

To evaluate the safety and effectiveness of the laparoscopic surgical system（Carina™ Surgical Platform, developed by Ronovo Surgical, Inc) for use in gastrectomy.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

robot group

Experimental group

Description:

Carina™ Surgical Platform, developed by Ronovo Surgical, Inc

Treatment:

Device: Carina™ Surgical Platform, developed by Ronovo Surgical, Inc