Evaluation,Efficacy,SafetyNCT06029608
Evaluation of the Efficacy and Safety of Magnetically-controlled Capsule Gastroscopy for Postoperative Assessment in Elderly Patients and Patients With Underlying Diseases
An observational study of Evaluation,Efficacy,Safety, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Evaluation,Efficacy,Safety
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2025to 30 Oct 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elderly patients (older than 65 years) and patients with underlying diseases (cardiovascular, respiratory, hemorrhagic diseases, etc.) who underwent surgery for gastric malignant tumors (including surgical resection and ESD).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200001
About this study
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.
Read the detailed description
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.
- Conditions
- Evaluation,Efficacy,Safety
- Keywords
- Magnetically-controlled Capsule Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Magnetically-controlled Capsule endoscopy group | Using magnetic-controlled capsule gastroscopy for postoperative assessment in elderly patients and patients with underlying diseases | |
| Conventional endoscopy group | Using conventional endoscopy for postoperative assessment in elderly patients and patients with underlying diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of gastric lesions (or postoperative complications)
Detection of gastric lesions (or postoperative complications)
Measured: 1 day
Secondary outcomes (4)
Upper gastrointestinal discomfort symptoms or not
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.
Measured: 1 day
Patients' comfort during the procedure
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.)
Measured: 1 day
Gastric clarity and visibility
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.
Measured: 1 day
Detection of small intestinal and colonic lesions in the magnetic-controlled capsule endoscopy group
Detection of small intestinal and colonic lesions in the magnetic-controlled capsule endoscopy group
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start6 Nov 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation,Efficacy,SafetyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaobo Li, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029608
- Sponsor's protocol ID
- Renji202302
- Status last verified
- Sep 2025
- First submitted
- 31 Aug 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Magnetically-controlled Capsule Gastroscopy for Postoperative Assessment in Elderly Patients and Patients With Underlying Diseases
- ClinicalTrials.gov ID
- NCT06029608
- Acronym / sponsor ID
- Renji202302
- Conditions
- Evaluation,Efficacy,Safety
- Keywords
- Magnetically-controlled Capsule Endoscopy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 6 Nov 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 8 Sep 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.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnetically-controlled Capsule endoscopy group | – | –Using magnetic-controlled capsule gastroscopy for postoperative assessment in elderly patients and patients with underlying diseases |
| Conventional endoscopy group | – | –Using conventional endoscopy for postoperative assessment in elderly patients and patients with underlying diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly patients (older than 65 years) and patients with underlying diseases (cardiovascular, respiratory, hemorrhagic diseases, etc.) who underwent surgery for gastric malignant tumors (including surgical resection and ESD).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of gastric lesions (or postoperative complications)
Time frame: 1 day
Detection of gastric lesions (or postoperative complications)
4 secondary outcomes
Upper gastrointestinal discomfort symptoms or not
Time frame: 1 day
Patients' comfort during the procedure
Time frame: 1 day
Gastric clarity and visibility
Time frame: 1 day
Detection of small intestinal and colonic lesions in the magnetic-controlled capsule endoscopy group
Time frame: 1 day
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 2 Oct 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Evaluation,Efficacy,Safety, run by Shanghai Jiao Tong University School of Medicine 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 2 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 2 Oct 2025. 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?
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 Hui-Min H Chen, MD (02168383015, chenhuimin@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of gastric lesions (or postoperative complications) (time frame: 1 day). 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 2 Oct 2025.