Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy

Not Applicable

Recruiting

• Conditions: Gastric Cancer
• Interventions: Device: Toumai Endoscopic surgery System

• Registration Number: NCT06073483
• Lead Sponsor: Hebei Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-07
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-05
• Last Update Submitted: 2023-10-05
• Study First Posted: 2023-10-10
• Last Update Posted: 2023-10-10
• Study Start: 2023-10-15
• Primary Completion: 2024-05-15
• Study Completion: 2024-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
5G remote gastrectomy	Toumai Endoscopic surgery System	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Intraoperative blood loss	The day of surgery
Surgical completion rate	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
Intraoperative system failure rate	The day of surgery

Trial Locations

Locations (1)

Department of General Surgery; 🇨🇳 Shijiazhuang, Hebei, China