Carina™ Surgical Platform for Minimal Radical Gastrectomy

NCT07113340 | Active Not Recruiting DMC

• 1 other identifier: China-made surgical robot 01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Robotic Gastrectomy; Stomach Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From the start of surgery to the end of surgery, up to 5 hours

Secondary Outcomes (15)

• Instrument Defects

  From the start of surgery to the end of surgery

• Incidence of Device-Related Adverse Events and Serious Adverse Events

  From the beginning of surgery until hospital discharge, up to 16 weeks

• Postoperative Mortality Rate

  Perioperative

• Incidence of Postoperative Complications

  From the beginning of surgery until hospital discharge, up to 16 weeks

• Pain Score

  Pain assessments were performed twice: once at 24 hours after surgery and once prior to hospital discharge.

Study Arms (1)

robot group

EXPERIMENTAL

Carina™ Surgical Platform, developed by Ronovo Surgical, Inc

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

Interventions

Carina™ Surgical Platform, developed by Ronovo Surgical, Inc DEVICE

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

robot group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

the Affiliated Hospital of QIngdao University

Qingdao, Shandong, 266000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Yanbing Zhou

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 14, 2025
• First Posted: August 8, 2025
• Study Start: May 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 31, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)