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NCT Number: NCT07655674

Endofaster Robot for Gastroesophageal Submucosal Tumors: A 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?

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Key information

Conditions

Gastric Submucosal Tumors

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Robot system

Device

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 endoscopy

Device

Conventional endoscopy without Robot

Primary outcomes

  1. Serosa integrity rate

    Time frame: perioperative

    En bloc resection rate with serosa preserved

Secondary outcomes

  1. Duration of the surgical procedure

    Time frame: Intraoperative

    Total duration of the surgical procedure

  2. Dissection time

    Time frame: perioperative

    Dissection time of tumor

  3. Intraoperative blood loss

    Time frame: perioperative

    Intraoperative blood loss during surgury

  4. Postoperative fever rate

    Time frame: Within 7 days after surgery

    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.

  5. Postoperative infection

    Time frame: Within 30 days after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chenhuan Tan

CONTACT

[email protected]

+86 18860928860

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Registry information

Official study title

Effectiveness and Safety of the Endofaster Surgical Robot System for Precise Dissection of Gastroesophageal Submucosal Tumors: A Single-Center Randomized Controlled Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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