Exploratory Study of Single-port Robot-assisted Gastrectomy

NCT06201585 | Unknown

• 1 other identifier: FUTURE-05
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• The rate of intraoperative complications

  Intraoperative complications, including organ injury and vascular injury, were evaluated

  The day of surgery

• 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

Other Outcomes (6)

• Intraoperative system failure rate

  The day of surgery

• Surgical completion rate

  The day of surgery

• Intraoperative blood loss

  The day of surgery

Study Arms (1)

Single-port robot-assisted gastrectomy

EXPERIMENTAL

SHURUI Endoscopic Surgical Robotic System (SR-ENS-600)

Device: SHURUI Endoscopic Surgical Robotic System (SR-ENS-600)

Interventions

SHURUI Endoscopic Surgical Robotic System (SR-ENS-600) DEVICE

SHURUI Endoscopic Surgical Robotic System (SR-ENS-600)

Single-port robot-assisted gastrectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients with severe heart, lung, brain, liver, or kidney diseases can not tolerate surgery or anesthesia;
• those who cannot tolerate pneumoperitoneum;
• patients with serious systemic diseases that are not suitable for surgical treatment according to the judgment of the investigator;
• 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);
• patients with active pulmonary tuberculosis;
• 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;
• with epilepsy, psychiatric history or cognitive impairment;
• pregnant and lactating women;
• 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;
• participants who participated in other interventional clinical trials within 3 months before screening;
• other circumstances that the investigator deemed inappropriate to participate in the trial.

Sponsors & Collaborators

• Hebei Medical University: lead

Study Sites (1)

Department of General Surgery

Shijiazhuang, Hebei, 050011, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Yuan Tian

CONTACT

800-555-5555; tangy0767@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hebei Medical University

Study Record Dates

• First Submitted: December 30, 2023
• First Posted: January 11, 2024
• Study Start: February 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: January 11, 2024

Record last verified: 2023-12

Locations

CN (1)