Gastric Submucosal TumorsNCT07655674
Endofaster Robot for Gastroesophageal Submucosal Tumors: A Randomized Controlled Study
A study testing Robot system and Non-robotic conventional endoscopy in people with Gastric Submucosal Tumors, run by The First Affiliated Hospital of Soochow University.
Trial summary
In endoscopic treatment for gastric submucosal tumors arising from the muscularis propria, does robot-assisted surgery yield a higher serosa preservation rate, shorter operative time and lower complication rates than conventional endoscopic procedures? Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Submucosal Tumors
- What is being tested?
- Robot system and Non-robotic conventional endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged 18 to 80 years old;
- Submucosal tumors originating from the muscularis propria of gastric fundus, highly suspected as gastrointestinal stromal tumor (GIST) confirmed by endoscopic ultrasonography (EUS) and contrast-enhanced computed tomography (CT);
- Tumor diameter ranging from 1.0 cm to 3.0 cm;
- No active ulcer or bleeding on the lesion surface before operation;
- American Society of Anesthesiologists (ASA) physical status class I-III;
- Voluntarily signed written informed consent.
Who cannot join
- Tumor adhesion to serosa with unclear interface shown on EUS;
- High-risk GIST or distant metastasis indicated by imaging or endoscopy;
- History of gastric surgery or radiotherapy;
- High bleeding risk including coagulation disorders and patients unable to discontinue anticoagulant medications;
- Pregnant or breastfeeding women;
- Failure to cooperate with follow-up.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness and Safety of the Endofaster Surgical Robot System for Precise Dissection of Gastroesophageal Submucosal Tumors: A Single-Center Randomized Controlled Study
In endoscopic treatment for gastric submucosal tumors arising from the muscularis propria, does robot-assisted surgery yield a higher serosa preservation rate, shorter operative time and lower complication rates than conventional endoscopic procedures?
Read the detailed description
For endoscopic treatment of gastric submucosal tumors originating from the muscularis propria, this study aims to explore whether robot-assisted therapy can improve serosa preservation rate, shorten operative time and reduce complications compared with conventional endoscopic surgery.
- Conditions
- Gastric Submucosal Tumors
- Being tested
- Robot system, Non-robotic conventional endoscopy
- Keywords
- gastric submucosal tumors, Robotic endoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot systemDevice
After Marking and mucosal incision，Grasp the tumor or its pedicle with the robotic flexible arm, apply continuous and steady traction toward the luminal side to dynamically expose the anatomical space between the tumor capsule and normal muscular layer.
Non-robotic conventional endoscopyDevice
Conventional endoscopy without Robot
| Study group | Role | What they receive |
|---|---|---|
| RG（Robot group） | Experimental | 1.Marking and mucosal incision.2.Grasp the tumor or its pedicle with the robotic flexible arm, apply continuous and steady traction toward the luminal side to dynamically expose the anatomical space between the tumor capsule and normal muscular layer.3.Perform meticulous dissection along the capsule-muscular layer interface using an ESD knife, and preserve the integrity of the serosa as much as possible.4.En bloc resection and removal of the tumor.5.Verification of serosal integrity: The procedure can be completed only if air/water insufflation test shows negative results. Mucosal defects are closed by standard techniques. Receives: Device: Robot system |
| TG（Traditional Group） | Active comparator | The procedures are performed by surgeons of equivalent seniority via conventional endoscopic full-thickness resection (EFTR) or modified endoscopic submucosal dissection (modified ESD). If a safe dissection plane cannot be established, full-thickness incision is conducted followed by closure using over-the-scope clip (OTSC), covered stent or suturing techniques. Leakage is assessed and managed in accordance with standard protocols. Receives: Device: Non-robotic conventional endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serosa integrity rate
En bloc resection rate with serosa preserved
Measured: perioperative
Secondary outcomes (5)
Duration of the surgical procedure
Total duration of the surgical procedure
Measured: Intraoperative
Dissection time
Dissection time of tumor
Measured: perioperative
Intraoperative blood loss
Intraoperative blood loss during surgury
Measured: perioperative
Postoperative fever rate
Postoperative fever is defined as a body temperature ≥ 37.5 ℃ within 7 days after surgery. All febrile cases during this period are included, including non-infectious absorption fever.
Measured: Within 7 days after surgery
Postoperative infection
Postoperative infection is diagnosed when body temperature reaches ≥ 38.5 ℃, or temperature ≥ 38.0 ℃ persists for more than 3 consecutive days starting from postoperative day 3. Diagnosis shall be confirmed by clinical symptoms, abnormal laboratory inflammatory indicators or positive microbial culture results. Simple absorption fever is excluded.
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Submucosal TumorsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rui Li, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655674
- Sponsor's protocol ID
- 2026250
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The shared datasets cover all collected de-identified individual participant data related to this trial, such as demographic data, imaging findings, surgical data, complication records and pathological results. No personal identifiable information will be retained. Data will be available to qualified researchers for legitimate scientific research use.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of the Endofaster Surgical Robot System for Precise Dissection of Gastroesophageal Submucosal Tumors: A Single-Center Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07655674
- Acronym / sponsor ID
- 2026250
- Conditions
- Gastric Submucosal Tumors
- Keywords
- gastric submucosal tumors, Robotic endoscope
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 18 Jun 2026 (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.
In endoscopic treatment for gastric submucosal tumors arising from the muscularis propria, does robot-assisted surgery yield a higher serosa preservation rate, shorter operative time and lower complication rates than conventional endoscopic procedures?
Detailed description
For endoscopic treatment of gastric submucosal tumors originating from the muscularis propria, this study aims to explore whether robot-assisted therapy can improve serosa preservation rate, shorten operative time and reduce complications compared with conventional endoscopic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RG（Robot group） | Experimental | Device: Robot system1.Marking and mucosal incision.2.Grasp the tumor or its pedicle with the robotic flexible arm, apply continuous and steady traction toward the luminal side to dynamically expose the anatomical space between the tumor capsule and normal muscular layer.3.Perform meticulous dissection along the capsule-muscular layer interface using an ESD knife, and preserve the integrity of the serosa as much as possible.4.En bloc resection and removal of the tumor.5.Verification of serosal integrity: The procedure can be completed only if air/water insufflation test shows negative results. Mucosal defects are closed by standard techniques. |
| TG（Traditional Group） | Active comparator | Device: Non-robotic conventional endoscopyThe procedures are performed by surgeons of equivalent seniority via conventional endoscopic full-thickness resection (EFTR) or modified endoscopic submucosal dissection (modified ESD). If a safe dissection plane cannot be established, full-thickness incision is conducted followed by closure using over-the-scope clip (OTSC), covered stent or suturing techniques. Leakage is assessed and managed in accordance with standard protocols. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 to 80 years old;
- Submucosal tumors originating from the muscularis propria of gastric fundus, highly suspected as gastrointestinal stromal tumor (GIST) confirmed by endoscopic ultrasonography (EUS) and contrast-enhanced computed tomography (CT);
- Tumor diameter ranging from 1.0 cm to 3.0 cm;
- No active ulcer or bleeding on the lesion surface before operation;
- American Society of Anesthesiologists (ASA) physical status class I-III;
Key exclusion criteria (6 listed)
- Tumor adhesion to serosa with unclear interface shown on EUS;
- High-risk GIST or distant metastasis indicated by imaging or endoscopy;
- History of gastric surgery or radiotherapy;
- High bleeding risk including coagulation disorders and patients unable to discontinue anticoagulant medications;
- Pregnant or breastfeeding women;
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 |
|---|---|---|
| Robot systemAfter Marking and mucosal incision，Grasp the tumor or its pedicle with the robotic flexible arm, apply continuous and steady traction toward the luminal side to dynamically expose the anatomical space between the tumor capsule and normal muscular layer. | Device | RG（Robot group） |
| Non-robotic conventional endoscopyConventional endoscopy without Robot | Device | TG（Traditional Group） |
Primary outcome
Serosa integrity rate
Time frame: perioperative
En bloc resection rate with serosa preserved
5 secondary outcomes
Duration of the surgical procedure
Time frame: Intraoperative
Dissection time
Time frame: perioperative
Intraoperative blood loss
Time frame: perioperative
Postoperative fever rate
Time frame: Within 7 days after surgery
Postoperative infection
Time frame: Within 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Yes. The shared datasets cover all collected de-identified individual participant data related to this trial, such as demographic data, imaging findings, surgical data, complication records and pathological results. No personal identifiable information will be retained. Data will be available to qualified researchers for legitimate scientific research use.
Related trials for Gastric Submucosal Tumors
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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.
Rui Li principal investigator
The First Affiliated Hospital of Soochow University
Questions about this trial
What is this clinical trial studying?
A study testing Robot system and Non-robotic conventional endoscopy in people with Gastric Submucosal Tumors, run by The First Affiliated Hospital of Soochow University.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chenhuan Tan (+86 18860928860, tanchenhuan2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serosa integrity rate (time frame: perioperative). 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 18 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.