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Trial Title:
Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy
NCT ID:
NCT06073483
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Toumai Endoscopic surgery System
Description:
5G remote gastrectomy on subjects using the Toumai endoscopic surgery system
Arm group label:
5G remote gastrectomy
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of General Surgery
Address:
City:
Shijiazhuang
Zip:
050011
Country:
China
Status:
Recruiting
Contact:
Last name:
Qun Zhao, Doctor
Phone:
+8613930162111
Email:
zhaoqun516@yahoo.com.cn
Investigator:
Last name:
Qun Zhao, Dortor
Email:
Principal Investigator
Start date:
October 15, 2023
Completion date:
June 15, 2024
Lead sponsor:
Agency:
Hebei Medical University
Agency class:
Other
Source:
Hebei Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06073483
