Carina™ Surgical Platform for Minimal Radical Gastrectomy

NCT ID: NCT07113340

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Robotic Gastrectomy; Stomach Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

robot group

Carina™ Surgical Platform, developed by Ronovo Surgical, Inc

Group Type: EXPERIMENTAL

Carina™ Surgical Platform, developed by Ronovo Surgical, Inc

Intervention Type: DEVICE

A modular surgical robot that offers greater flexibility in the number of instrument arms and surgical layout options.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: lead

Responsible Party

zhouyanbing

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanbing Zhou

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Qingdao University

Locations

the Affiliated Hospital of QIngdao University

Qingdao, Shandong, China

Countries

China

Other Identifiers

China-made surgical robot 01

Identifier Type: -

Identifier Source: org_study_id