Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Hebei Medical University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- The rate of intraoperative complications
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
The rate of intraoperative complications
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
- Intraoperative system failure rate(The day of surgery)
Investigators
Qun Zhao
Principal Investigator
Hebei Medical University