Gastric Cancer
Conditions
Brief summary
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.
Interventions
DEVICEToumai Endoscopic surgery System
5G remote gastrectomy on subjects using the Toumai endoscopic surgery system
Sponsors
Hebei Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 18 years old ≤ actual age ≤80 years old. 2. Patients requiring gastrointestinal endoscopic surgery. 3. Willing to cooperate with and complete the study follow-up and related examinations. 4. Voluntarily participate in the study and sign the informed consent in person.
Exclusion criteria
1. Have serious cardiovascular or circulatory disease and cannot tolerate surgery. 2. Participated in other clinical trials within the last 3 months. 3. Inability to understand trial requirements, or inability to complete the study follow-up plan. 4. Researchers believe that there are other circumstances that are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of intraoperative complications | The day of surgery | 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 rate of postoperative complications | Postoperative 30 days | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative blood loss | The day of surgery |
| Operation time | The day of surgery |
| Intraoperative system failure rate | The day of surgery |
| Intraoperative instrument operation error rate | The day of surgery |
| Preoperative device assembly time | The day of surgery |
| Surgical completion rate | The day of surgery |
Countries
China
Outcome results
None listed