Gastric CancerNCT06073483
Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy
A study testing Toumai Endoscopic surgery System 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 5G remote gastrectomy on subjects using the Toumai endoscopic surgery system, and explore and evaluate the safety and efficacy of this… 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?
- Toumai Endoscopic surgery System
- 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
- 15 Oct 2023to 15 Jun 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
- 18 years old ≤ actual age ≤80 years old.
- Patients requiring gastrointestinal endoscopic surgery.
- Willing to cooperate with and complete the study follow-up and related examinations.
- Voluntarily participate in the study and sign the informed consent in person.
Who cannot join
- Have serious cardiovascular or circulatory disease and cannot tolerate surgery.
- Participated in other clinical trials within the last 3 months.
- Inability to understand trial requirements, or inability to complete the study follow-up plan.
- Researchers believe that there are other circumstances that are not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of General Surgery
Shijiazhuang, Hebei, 050011
Qun Zhao, Doctor, +8613930162111, zhaoqun516@yahoo.com.cn
Qun Zhao, Dortor
About this study
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 5G remote gastrectomy on subjects using the Toumai endoscopic surgery system, and explore and evaluate the safety and efficacy of this clinical application.
- Conditions
- Gastric Cancer
- Being tested
- Toumai Endoscopic surgery System
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toumai Endoscopic surgery SystemDevice
5G remote gastrectomy on subjects using the Toumai endoscopic surgery system
| Study group | Role | What they receive |
|---|---|---|
| 5G remote gastrectomy | Experimental | Not described Receives: Device: Toumai Endoscopic surgery System |
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 using the Satava grading system to determine whether the occurrence of complications was related to the study instrument or surgery
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
Secondary outcomes (6)
Intraoperative system failure rate
Measured: The day of surgery
Surgical completion rate
Measured: The day of surgery
Intraoperative blood loss
Measured: The day of surgery
Operation time
Measured: The day of surgery
Preoperative device assembly time
Measured: The day of surgery
Intraoperative instrument operation error rate
Measured: The day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start15 Oct 2023 (estimated)
- Primary completion15 May 2024 (estimated)
- Study completion15 Jun 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
- NCT06073483
- Sponsor's protocol ID
- FUTURE-04
- Status last verified
- Oct 2023
- First submitted
- 7 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Toumai Endoscopic Surgery System for Remote Gastrectomy
- ClinicalTrials.gov ID
- NCT06073483
- Acronym / sponsor ID
- FUTURE-04
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hebei Medical UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (estimated)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 10 Oct 2023 (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 5G remote gastrectomy on subjects using the Toumai endoscopic surgery system, 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 |
|---|---|---|
| 5G remote gastrectomy | Experimental | Device: Toumai Endoscopic surgery System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old ≤ actual age ≤80 years old.
- Patients requiring gastrointestinal endoscopic surgery.
- Willing to cooperate with and complete the study follow-up and related examinations.
- Voluntarily participate in the study and sign the informed consent in person.
Key exclusion criteria (4 listed)
- Have serious cardiovascular or circulatory disease and cannot tolerate surgery.
- Participated in other clinical trials within the last 3 months.
- Inability to understand trial requirements, or inability to complete the study follow-up plan.
- Researchers believe that there are other circumstances that are not suitable for inclusion.
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 |
|---|---|---|
| Toumai Endoscopic surgery System5G remote gastrectomy on subjects using the Toumai endoscopic surgery system | Device | 5G remote gastrectomy |
Primary outcome
The rate of intraoperative complications
Time frame: The day of surgery
Intraoperative complications, including organ injury and vascular injury, were evaluated using the Satava grading system to determine whether the occurrence of complications was related to the study instrument or surgery
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.
6 secondary outcomes
Intraoperative system failure rate
Time frame: The day of surgery
Surgical completion rate
Time frame: The day of surgery
Intraoperative blood loss
Time frame: The day of surgery
Operation time
Time frame: The day of surgery
Preoperative device assembly time
Time frame: The day of surgery
Intraoperative instrument operation error rate
Time frame: The day of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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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 Toumai Endoscopic surgery System 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 4 inclusion and 4 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 10 Oct 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 10 Oct 2023.