Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy

Gastric Cancer Clinical Trial

Official title:

Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06073483
• Other study ID #: FUTURE-04
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: June 15, 2024

Study information

• Verified date: October 2023
• Source: Hebei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Device:
• Toumai Endoscopic surgery System
5G remote gastrectomy on subjects using the Toumai endoscopic surgery system

Locations

Country	Name	City	State
China	Department of General Surgery	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Intraoperative system failure rate		The day of surgery
Secondary	Surgical completion rate		The day of surgery
Secondary	Intraoperative blood loss		The day of surgery
Secondary	Operation time		The day of surgery
Secondary	Preoperative device assembly time		The day of surgery
Secondary	Intraoperative instrument operation error rate		The day of surgery