Exploratory Study of Single-port Robot-assisted Gastrectomy

NCT ID: NCT06201585

Last Updated: 2024-01-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-08-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single-port robot-assisted gastrectomy

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Interventions

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

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Qun Zhao

Hebei Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of General Surgery

Shijiazhuang, Hebei, China

Countries

China

Central Contacts

Yuan Tian

Role: CONTACT

tangy0767@126.com

800-555-5555

Facility Contacts

Yuan Tian

Role: primary

tangy0767@126.com

+8631186095348800-555-5555

Other Identifiers

FUTURE-05

Identifier Type: -

Identifier Source: org_study_id