Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable gastric-cancer
Started Oct 2023
Shorter than P25 for not_applicable gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2023
CompletedFirst Posted
Study publicly available on registry
October 10, 2023
CompletedStudy Start
First participant enrolled
October 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2024
CompletedOctober 10, 2023
October 1, 2023
7 months
September 7, 2023
October 5, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (6)
Intraoperative system failure rate
The day of surgery
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
- +1 more secondary outcomes
Study Arms (1)
5G remote gastrectomy
EXPERIMENTALInterventions
5G remote gastrectomy on subjects using the Toumai endoscopic surgery system
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of General Surgery
Shijiazhuang, Hebei, 050011, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 7, 2023
First Posted
October 10, 2023
Study Start
October 15, 2023
Primary Completion
May 15, 2024
Study Completion
June 15, 2024
Last Updated
October 10, 2023
Record last verified: 2023-10