NCT06027060

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Nov 2025Nov 2026

First Submitted

Initial submission to the registry

August 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
2.2 years until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

August 30, 2023

Last Update Submit

September 27, 2025

Conditions

NSAID-Associated Gastropathy

Keywords

Magnetically-controlled Capsule Endoscopy

Outcome Measures

Primary Outcomes (1)

  • Gastric diseases detected

    Gastric diseases detected

    1 day

Secondary Outcomes (5)

  • Gastric mucosal injury by Lanza score

    1 day

  • Gastric transit time

    1 day

  • Gastric cleanliness

    1 day

  • Effects of NSAID duration on gastric injury

    1 day

  • Effects of NSAID dosage on gastric injury

    1 day

Study Arms (2)

NSAIDs users

90 patients taking NSAIDs for over 3 months

non-NSAIDs users

90 non-NSAIDs users undergoing physical examination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Planned magnetically-controlled capsule gastroscopy
  • NSAID use \>3 months or no NSAID use
  • Informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, 200001, China

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

August 30, 2023

First Posted

September 7, 2023

Study Start

November 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)