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NCT Number: NCT06029608

Evaluation of the Efficacy and Safety of Magnetically-controlled Capsule Gastroscopy for Postoperative Assessment in Elderly Patients and Patients With Underlying Diseases

The objective of this prospective, observational, controlled clinical study is to use magnetically-controlled capsule gastroscopy for postoperative assessment in elderly patients and patients with underlying diseases, to evaluate its clinical efficacy and safety.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200001, China

About this study

Gastric cancer is the most common digestive tract malignancy in China, which severely impacts human health and quality of life. Currently, surgery is the main treatment for gastric cancer. Since the surgery removes part or all of the stomach for malignant tumor, various postoperative complications inevitably occur. The occurrence of postoperative complications is detrimental to the prognosis of patients. Therefore, regular follow-up after surgery is necessary to closely monitor for upper gastrointestinal symptoms and periodically examine intragastric lesions in order to make timely diagnosis and treatment, and improve quality of life. Standard endoscopy procedures often cause discomfort and poor compliance in elderly patients. Also, for patients with severe respiratory diseases, severe cardiocerebral vascular diseases, the risks of anesthesia are extremely high. Magnetic-controlled capsule gastroscopy has the advantages of being completely painless, convenient, highly accurate in diagnosis, and well-accepted by patients. It is more suitable for postoperative assessment in elderly patients and patients with underlying diseases.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Planned to undergo magnetic-controlled capsule gastroscopy or conventional endoscopy, and have undergone surgery for gastric malignant tumors (including surgical resection and ESD), elderly patients (older than 65 years) or patients with underlying diseases (cardiovascular, respiratory, hemorrhagic diseases, etc.);
  • Agree to participate in this clinical trial and sign the informed consent form.

Exclusion criteria

  • No surgical conditions or refuses abdominal surgery (Once the capsule is stuck it cannot be removed surgically);
  • Cardiac pacemakers (except MRI-compatible ones);
  • Electronic implants or metal foreign bodies;
  • Pregnant women;
  • Known or suspected GI obstruction, stenosis, fistula;
  • Dysphagia.

Treatment and study plan

Primary outcomes

  1. Detection of gastric lesions (or postoperative complications)

    Time frame: 1 day

    Detection of gastric lesions (or postoperative complications)

Secondary outcomes

  1. Upper gastrointestinal discomfort symptoms or not

    Time frame: 1 day

    Patients have or no upper gastrointestinal discomfort symptoms after surgery (such as nausea, vomiting, acid reflux, belching, bloating, postprandial fullness, and early satiety), judging by the patient's chief complaint.

  2. Patients' comfort during the procedure

    Time frame: 1 day

    Use BCS to evaluate patients' comfort during the procedure (BCS is Bruggrmann comfort scale, a 5-point scale of 0 to 4, with a higher score indicating higher comfort.)

  3. Gastric clarity and visibility

    Time frame: 1 day

    Assess the clarity and visibility of the stomach. The clarity and visibility of the field of vision is divided into three categories, that is, class I: the field of vision is clear, and the part and mucosa can be accurately observed; Class II: Vision is not clear, but can still distinguish the part; Class III: Cloudy vision, unable to distinguish the area.

  4. Detection of small intestinal and colonic lesions in the magnetic-controlled capsule endoscopy group

    Time frame: 1 day

    Detection of small intestinal and colonic lesions in the magnetic-controlled capsule endoscopy group

Study contacts

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

Hui-Min H Chen, MD

CONTACT

[email protected]

02168383015

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2023
Registry last updated
Oct 2, 2025

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.