Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy

• Sponsor: Hebei Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06073483
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Device: Toumai Endoscopic surgery System	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy
• Anticipated Study Start Date: Oct 15, 2023
• Anticipated Primary Completion Date: May 15, 2024
• Anticipated Study Completion Date: Jun 15, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The rate of intraoperative complications [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

2. The rate of postoperative complications [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.

Secondary Outcome Measures

1. Intraoperative system failure rate [The day of surgery]

2. Surgical completion rate [The day of surgery]

3. Intraoperative blood loss [The day of surgery]

4. Operation time [The day of surgery]

5. Preoperative device assembly time [The day of surgery]

6. Intraoperative instrument operation error rate [The day of surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of General Surgery	Shijiazhuang	Hebei	China	050011

Sponsors and Collaborators

• Hebei Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qun Zhao, Principal Investigator, Hebei Medical University
• ClinicalTrials.gov Identifier: NCT06073483
• Other Study ID Numbers: FUTURE-04
• First Posted: Oct 10, 2023
• Last Update Posted: Oct 10, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stomach Neoplasms

Study Results

No Results Posted as of Oct 10, 2023