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Status unknownNCT06073483Updated Oct 10, 2023

Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy

An interventional study of Toumai Endoscopic surgery System in Gastric Cancer, sponsored by Hebei Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by Hebei Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Gastric Cancer

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03

In context

Stomach Neoplasms

2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.

This study's planned enrollment of 10 is below the median of 66 across 2,143 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Hebei Medical University is the lead sponsor of 42 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    5G remote gastrectomy

    Device: Toumai Endoscopic surgery System

Interventions

  • DeviceToumai Endoscopic surgery System

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: The day of surgery

  2. 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.

    Time frame: Postoperative 30 days

Secondary outcomes

  1. Intraoperative system failure rate

    Time frame: The day of surgery

  2. Surgical completion rate

    Time frame: The day of surgery

  3. Intraoperative blood loss

    Time frame: The day of surgery

  4. Operation time

    Time frame: The day of surgery

  5. Preoperative device assembly time

    Time frame: The day of surgery

  6. Intraoperative instrument operation error rate

    Time frame: The day of surgery

07

Study locations

1 of 1 sites recruiting
  • Department of General Surgery
    Shijiazhuang, Hebei 050011, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06073483
Lead sponsor
Hebei Medical University
Responsible party
Qun Zhao (Principal Investigator, Hebei Medical University) — Principal investigator
First posted
Oct 10, 2023
Start date
Oct 15, 2023 (estimated)
Primary completion
May 15, 2024 (estimated)
Completion
Jun 15, 2024 (estimated)
Last update
Oct 10, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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