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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

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 15 studies in Stomach Neoplasms by Hebei Medical University — 4 open to participants now, 5 under way, none of them phase 3. Stomach Neoplasms · Hebei Medical University.

Planned enrollment
13th of 14
10 · median 48
Started
2024
with 1 other
No phase
4 of 15
2 open now
Registered
12th of 15
by date

Among the 15 studies in Stomach Neoplasms by Hebei Medical University, this one is the 13th largest by planned enrollment of the 14 interventional ones, is one of 2 that started in 2024, is one of 4 with no phase, and was the 12th registered.

By phase

15 studies; the count open now beside each. This study's row is marked.

Phase 25 · 1 open
No phasethis study4 · 2 open
Phase 2/33 · 0 open
Phase 42 · 0 open
Observational1 · 1 open

By the year they started

First in 2012; this study’s year is marked. 2 started in 2024.

Size and results

Median enrollment 48 across the 14 interventional studies, 300 across the 1 observational. Of the 1 that completed or were terminated, 0 (0%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 15 studies in Stomach Neoplasms by Hebei Medical University, or all of them as a file.
02

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.

03

Conditions studied

  • Gastric Cancer

Browse trials for

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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 .

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. antibody positive; surface antigen (HbsAg) positive and hepatitis B virus DNA (HBV-DNA) copy number higher than the detection limit or normal range; 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

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)

06

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

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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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Discussion

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