Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy

Hebei Medical University

Status: Enrolling

Conditions: Gastric Cancer

Treatments: Device: Toumai Endoscopic surgery System

Study type: Interventional

Funder types: Other

Identifiers

NCT06073483

FUTURE-04

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

5G remote gastrectomy

Experimental group

Treatment:

Device: Toumai Endoscopic surgery System