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Not yet recruitingNCT06201585Updated Jan 11, 2024

Exploratory Study of Single-port Robot-assisted Gastrectomy

An interventional study of SHURUI Endoscopic Surgical Robotic System (SR-ENS-600) in Gastric Cancer, sponsored by Hebei Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-01-11.

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

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

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Conditions studied

  • Gastric Cancer

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Who can participate

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

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

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.
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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
    Single-port robot-assisted gastrectomy

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

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

Interventions

  • DeviceSHURUI Endoscopic Surgical Robotic System (SR-ENS-600)

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

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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

    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

Other 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

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Study locations

1 site
  • Department of General Surgery
    Shijiazhuang, Hebei 050011, China
    • Yuan Tian · Contact · tangy0767@126.com · +8631186095348800-555-5555
    • Qun Zhao, Doctor · Principal investigator
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Registry details

Key details

Study ID
NCT06201585
Lead sponsor
Hebei Medical University
Responsible party
Qun Zhao (Hebei Medical University, Hebei Medical University) — Principal investigator
First posted
Jan 11, 2024
Start date
Feb 1, 2024 (estimated)
Primary completion
Jul 1, 2024 (estimated)
Completion
Aug 1, 2024 (estimated)
Last update
Jan 11, 2024

Study contacts

Yuan Tian
Contact
tangy0767@126.com
800-555-5555

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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