Back to resultsExploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy
Primary Purpose
Gastric Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Toumai Endoscopic surgery System
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
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.
Sites / Locations
- Department of General SurgeryRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
5G remote gastrectomy
Arm Description
Outcomes
Primary Outcome Measures
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 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.
Secondary Outcome Measures
Intraoperative system failure rate
Surgical completion rate
Intraoperative blood loss
Operation time
Preoperative device assembly time
Intraoperative instrument operation error rate
Full Information
NCT ID
NCT06073483
First Posted
September 7, 2023
Last Updated
October 5, 2023
Sponsor
Hebei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT06073483
Brief Title
Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy
Official Title
Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
May 15, 2024 (Anticipated)
Study Completion Date
June 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
5G remote gastrectomy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Toumai Endoscopic surgery System
Intervention Description
5G remote gastrectomy on subjects using the Toumai endoscopic surgery system
Primary Outcome Measure Information:
Title
The rate of intraoperative complications
Description
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
Time Frame
The day of surgery
Title
The rate of postoperative complications
Description
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.
Time Frame
Postoperative 30 days
Secondary Outcome Measure Information:
Title
Intraoperative system failure rate
Time Frame
The day of surgery
Title
Surgical completion rate
Time Frame
The day of surgery
Title
Intraoperative blood loss
Time Frame
The day of surgery
Title
Operation time
Time Frame
The day of surgery
Title
Preoperative device assembly time
Time Frame
The day of surgery
Title
Intraoperative instrument operation error rate
Time Frame
The day of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of General Surgery
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qun Zhao, Doctor
Phone
+8613930162111
Email
zhaoqun516@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Qun Zhao, Dortor
12. IPD Sharing Statement
Learn more about this trial
Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy
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