NSAID-Associated GastropathyNCT06027060
Observational Study on Monitoring NSAID-Induced Gastropathy in Patients Using Magnetically-Controlled Capsule Gastroscopy
An observational study of NSAID-Associated Gastropathy, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The objective of this study is to observe gastric mucosal injuries in NSAID and non-NSAID users with magnetically-controlled capsule gastroscopy, and explore the effects of NSAIDs on gastric mucosal damage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- NSAID-Associated Gastropathy
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 1 Nov 2026
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ninety patients receiving NSAIDS (more than 3 months) and undergoing magnetron capsule gastroscopy at Renji Hospital were included, and 90 patients not taking NSAIDS and undergoing magnetron capsule gastroscopy at the same time were included.
Who may be able to join
- Planned magnetically-controlled capsule gastroscopy
- NSAID use >3 months or no NSAID use
- Informed consent
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.
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 study is to observe gastric mucosal injuries in NSAID and non-NSAID users with magnetically-controlled capsule gastroscopy, and explore the effects of NSAIDs on gastric mucosal damage.
Read the detailed description
Non-steroidal anti-inflammatory drugs are widely used in all kinds of people in China. A major limitation to their use is the adverse effects they cause on the gastrointestinal tract, including the formation of stomach lesions, ulcers due to stress reactions, and damage to the healing of gastric ulcers. The purpose of this prospective, single-center study was to monitor the gastric mucosal injury in patients with and without NSAIDs using magnetron capsule gastroscopy, and to explore the effect of NSaids on gastric mucosal injury.
For people taking NSAIDs, it is necessary to regularly detect gastric mucosal damage, and timely intervention treatment is required if relevant lesions are found, and the medication plan is adjusted. Magnetron capsule gastroscope has the advantages of comfort, safety, no anesthesia, no risk of cross infection, etc. It is highly accepted by the population, and is a beneficial supplement to traditional gastroscopy, so that some people with absolute or relative contraindications of traditional gastroscopy can get timely endoscopy, and can be diagnosed and treated early.
- Conditions
- NSAID-Associated Gastropathy
- 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 |
|---|---|---|
| NSAIDs users | 90 patients taking NSAIDs for over 3 months | |
| non-NSAIDs users | 90 non-NSAIDs users undergoing physical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric diseases detected
Gastric diseases detected
Measured: 1 day
Secondary outcomes (5)
Gastric mucosal injury by Lanza score
Gastric mucosal injury by Lanza score
Measured: 1 day
Gastric transit time
Gastric transit time
Measured: 1 day
Gastric cleanliness
Gastric cleanliness
Measured: 1 day
Effects of NSAID duration on gastric injury
Effects of NSAID duration on gastric injury
Measured: 1 day
Effects of NSAID dosage on gastric injury
Effects of NSAID dosage on gastric injury
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 posted7 Sep 2023
- Study start1 Nov 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Why it stopped: Failure of equipment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSAID-Associated GastropathyStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- 180 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
- NCT06027060
- Sponsor's protocol ID
- Renjixh202301
- Status last verified
- Sep 2025
- First submitted
- 30 Aug 2023
- Last updated
- 2 Oct 2025
- Results posted
- 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
- Observational Study on Monitoring NSAID-Induced Gastropathy in Patients Using Magnetically-Controlled Capsule Gastroscopy
- ClinicalTrials.gov ID
- NCT06027060
- Acronym / sponsor ID
- Renjixh202301
- Conditions
- NSAID-Associated Gastropathy
- Keywords
- Magnetically-controlled Capsule Endoscopy
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Failure of equipment
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 7 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 study is to observe gastric mucosal injuries in NSAID and non-NSAID users with magnetically-controlled capsule gastroscopy, and explore the effects of NSAIDs on gastric mucosal damage.
Detailed description
Non-steroidal anti-inflammatory drugs are widely used in all kinds of people in China. A major limitation to their use is the adverse effects they cause on the gastrointestinal tract, including the formation of stomach lesions, ulcers due to stress reactions, and damage to the healing of gastric ulcers. The purpose of this prospective, single-center study was to monitor the gastric mucosal injury in patients with and without NSAIDs using magnetron capsule gastroscopy, and to explore the effect of NSaids on gastric mucosal injury.
For people taking NSAIDs, it is necessary to regularly detect gastric mucosal damage, and timely intervention treatment is required if relevant lesions are found, and the medication plan is adjusted. Magnetron capsule gastroscope has the advantages of comfort, safety, no anesthesia, no risk of cross infection, etc. It is highly accepted by the population, and is a beneficial supplement to traditional gastroscopy, so that some people with absolute or relative contraindications of traditional gastroscopy can get timely endoscopy, and can be diagnosed and treated early.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSAIDs users | – | –90 patients taking NSAIDs for over 3 months |
| non-NSAIDs users | – | –90 non-NSAIDs users undergoing physical examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ninety patients receiving NSAIDS (more than 3 months) and undergoing magnetron capsule gastroscopy at Renji Hospital were included, and 90 patients not taking NSAIDS and undergoing magnetron capsule gastroscopy at the same time were included.
Key inclusion criteria (3 listed)
- Planned magnetically-controlled capsule gastroscopy
- NSAID use >3 months or no NSAID use
- Informed consent
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
Gastric diseases detected
Time frame: 1 day
Gastric diseases detected
5 secondary outcomes
Gastric mucosal injury by Lanza score
Time frame: 1 day
Gastric transit time
Time frame: 1 day
Gastric cleanliness
Time frame: 1 day
Effects of NSAID duration on gastric injury
Time frame: 1 day
Effects of NSAID dosage on gastric injury
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 NSAID-Associated Gastropathy, 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 3 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: paused, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric diseases detected (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.