Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy

October 5, 2023 updated by: Qun Zhao, Hebei Medical University
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Recruiting
        • Department of General Surgery
        • Principal Investigator:
          • Qun Zhao, Dortor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5G remote gastrectomy
Device: Toumai Endoscopic surgery System
5G remote gastrectomy on subjects using the Toumai endoscopic surgery system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 day of 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.
Postoperative 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Intraoperative system failure rate
Time Frame: The day of surgery
The day of surgery
Surgical completion rate
Time Frame: The day of surgery
The day of surgery
Intraoperative blood loss
Time Frame: The day of surgery
The day of surgery
Operation time
Time Frame: The day of surgery
The day of surgery
Preoperative device assembly time
Time Frame: The day of surgery
The day of surgery
Intraoperative instrument operation error rate
Time Frame: The day of surgery
The day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 15, 2023

Primary Completion (Estimated)

May 15, 2024

Study Completion (Estimated)

June 15, 2024

Study Registration Dates

First Submitted

September 7, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Estimated)

October 9, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUTURE-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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