Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy

Study Overview
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Brief Summary
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This clinical study was a prospective, single-center, single-arm exploratory study. Subjects who meet the inclusion criteria will be enrolled in this study, where surgeons will perform 5G remote gastrectomy on subjects using the Toumai endoscopic surgery system, and explore and evaluate the safety and efficacy of this clinical application.

Official Title
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Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy

Conditions
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Gastric Cancer

Intervention / Treatment
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* Device: Toumai Endoscopic surgery System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old ≤ actual age ≤80 years old. Patients requiring gastrointestinal endoscopic surgery. Willing to cooperate with and complete the study follow-up and related examinations. Voluntarily participate in the study and sign the informed consent in person. Exclusion Criteria: Have serious cardiovascular or circulatory disease and cannot tolerate surgery. Participated in other clinical trials within the last 3 months. Inability to understand trial requirements, or inability to complete the study follow-up plan. Researchers believe that there are other circumstances that are not suitable for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5G remote gastrectomy<br> | Device: Toumai Endoscopic surgery System<br>* 5G remote gastrectomy on subjects using the Toumai endoscopic surgery system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of intraoperative complications | Intraoperative complications, including organ injury and vascular injury, were evaluated using the Satava grading system to determine whether the occurrence of complications was related to the study instrument or surgery | The day of surgery | 
| The rate of postoperative complications | Postoperative complications, including postoperative bleeding, fever, and incisional infection, were evaluated using the Clavien-Dindo grading system to determine whether the occurrence of complications was related to the study instrument or surgery. | Postoperative 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative system failure rate |  | The day of surgery | 
| Surgical completion rate |  | The day of surgery | 
| Intraoperative blood loss |  | The day of surgery | 
| Operation time |  | The day of surgery | 
| Preoperative device assembly time |  | The day of surgery | 
| Intraoperative instrument operation error rate |  | The day of surgery |