Gastric CancerNCT06201585
Exploratory Study of Single-port Robot-assisted Gastrectomy
A study testing SHURUI Endoscopic Surgical Robotic System (SR-ENS-600) in people with Gastric Cancer, run by Hebei Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- SHURUI Endoscopic Surgical Robotic System (SR-ENS-600)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of General Surgery
Shijiazhuang, Hebei, 050011
Yuan Tian, +8631186095348800-555-5555, tangy0767@126.com
Qun Zhao, Doctor
About this study
Official title: 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.
- Conditions
- Gastric Cancer
- Being tested
- SHURUI Endoscopic Surgical Robotic System (SR-ENS-600)
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHURUI Endoscopic Surgical Robotic System (SR-ENS-600)Device
SHURUI Endoscopic Surgical Robotic System (SR-ENS-600)
| Study group | Role | What they receive |
|---|---|---|
| Single-port robot-assisted gastrectomy | Experimental | SHURUI Endoscopic Surgical Robotic System (SR-ENS-600) Receives: Device: SHURUI Endoscopic Surgical Robotic System (SR-ENS-600) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of intraoperative complications
Intraoperative complications, including organ injury and vascular injury, were evaluated
Measured: 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.
Measured: Postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qun Zhao, Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201585
- Sponsor's protocol ID
- FUTURE-05
- Status last verified
- Dec 2023
- First submitted
- 30 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-port Robot-assisted Surgery for Gastric Cancer
- ClinicalTrials.gov ID
- NCT06201585
- Acronym / sponsor ID
- FUTURE-05
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-port robot-assisted gastrectomy | Experimental | Device: SHURUI Endoscopic Surgical Robotic System (SR-ENS-600)SHURUI Endoscopic Surgical Robotic System (SR-ENS-600) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHURUI Endoscopic Surgical Robotic System (SR-ENS-600)SHURUI Endoscopic Surgical Robotic System (SR-ENS-600) | Device | Single-port robot-assisted gastrectomy |
Primary outcome
The rate of intraoperative complications
Time frame: The day of surgery
Intraoperative complications, including organ injury and vascular injury, were evaluated
The rate of postoperative complications
Time frame: Postoperative 30 days
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHURUI Endoscopic Surgical Robotic System (SR-ENS-600) in people with Gastric Cancer, run by Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan Tian (800-555-5555, tangy0767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of intraoperative complications (time frame: The day of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.