Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy

NCT ID: NCT06073483

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-15

Study Completion Date

2024-06-15

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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5G remote gastrectomy

Group Type EXPERIMENTAL

Toumai Endoscopic surgery System

Intervention Type DEVICE

5G remote gastrectomy on subjects using the Toumai endoscopic surgery system

Interventions

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Toumai Endoscopic surgery System

5G remote gastrectomy on subjects using the Toumai endoscopic surgery system

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hebei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Qun Zhao

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of General Surgery

Shijiazhuang, Hebei, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Qun Zhao, Doctor

Role: primary

+8613930162111

Other Identifiers

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FUTURE-04

Identifier Type: -

Identifier Source: org_study_id

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