Exploratory Study of Single-port Robot-assisted Gastrectomy

Single-port Robot-assisted Surgery for Gastric Cancer

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 single-port robot-assisted gastrectomy, and explore and evaluate the safety and efficacy of this clinical application.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Device: SHURUI Endoscopic Surgical Robotic System (SR-ENS-600)

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuan Tian; Phone Number: 800-555-5555; Email: tangy0767@126.com

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • Department of General Surgery
      • Contact: Yuan Tian; Phone Number: +8631186095348800-555-5555; Email: tangy0767@126.com
      • Principal Investigator: Qun Zhao, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years old and age ≤80 years old, regardless of gender;
2. patients who met the surgical indications and were confirmed by the investigator to be in need of laparoscopic surgery.
3. patients with American Society of Anesthesiologists (ASA) physical status classification ⅰ-ⅲ.
4. Be able to cooperate with the completion of visits and related examinations specified in the protocol.
5. Subjects voluntarily participated in the clinical trial and agreed or their guardians agreed to sign an informed consent.

Exclusion Criteria:

1. patients with severe heart, lung, brain, liver, or kidney diseases can not tolerate surgery or anesthesia;
2. those who cannot tolerate pneumoperitoneum;
3. patients with serious systemic diseases that are not suitable for surgical treatment according to the judgment of the investigator;
4. patients with a history of severe bleeding disease, hematopoietic dysfunction or coagulation dysfunction, who are not suitable for surgical treatment according to the judgment of the investigator, and long-term use of anticoagulant and antiplatelet drugs (antiplatelet aggregation drugs were discontinued less than 1 week before surgery);
5. patients with active pulmonary tuberculosis;
6. HIV antibody positive; Hepatitis B surface antigen (HbsAg) positive and hepatitis B virus DNA (HBV-DNA) copy number higher than the detection limit or normal range; Hepatitis C virus (HCV) antibody positive; Patients with positive treponema pallidum antibody and high risk of infection judged by the researcher;
7. with epilepsy, psychiatric history or cognitive impairment;
8. pregnant and lactating women;
9. Extensive and severe adhesion in the abdominal cavity caused the inability to perform puncture to establish pneumoperitoneum, and it was difficult to isolate and expose the lesion; A history of major abdominal surgery and abdominal radiotherapy were included, according to the investigator's judgment Situations where there is a risk of extensive adhesion;
10. participants who participated in other interventional clinical trials within 3 months before screening;
11. other circumstances that the investigator deemed inappropriate to participate in the trial.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-port robot-assisted gastrectomy; SHURUI Endoscopic Surgical Robotic System (SR-ENS-600)	Device: SHURUI Endoscopic Surgical Robotic System (SR-ENS-600); SHURUI Endoscopic Surgical Robotic System (SR-ENS-600)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Postoperative 30 days
The rate of intraoperative complications	Intraoperative complications, including organ injury and vascular injury, were evaluated	The day of surgery

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hebei Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: December 30, 2023
• First Submitted That Met QC Criteria: December 30, 2023
• First Posted (Estimated): January 11, 2024

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: December 30, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: FUTURE-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No