N/A
Completed N=25
Detachable String Magnetically Controlled Capsule Endoscopy for Completely Viewing of Esophagus and Stomach
Outpatients
Source: ClinicalTrials.gov NCT03457909 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Number of Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach — 25 Participants
Summary
The purpose of the study is to determine the safety and feasibility of the new technique,detachable string magnetically controlled capsule endoscopy(DS-MCE)for evaluating gastric and esophagus diseases.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach |
25 | — |
| SECONDARY Number of DS-MCE Associated Adverse Events |
— | — |
| SECONDARY Duration of Time Capsule is Within the Esophagus |
6.2 | — |
| SECONDARY Z-line Visualization |
20 | — |
| SECONDARY Quality Score of Z-line Images |
0.68 | — |
| SECONDARY Degree of Comfort |
0.96 | — |
Eligibility Criteria
Inclusion Criteria
- outpatients who have esophagus symptoms.
Exclusion Criteria
- known or suspected complex history of gastrointestinal obstruction, stenosis or fistula.
- dysphagia or delayed gastric emptying.
- known or suspected possibility of active bleeding of digestive tract.
- a history of abdominal operation.
- pacemaker implantation and gastrointestinal pacemaker users.
- patients who are allergic to simethicone or pronase.
- pregnant women,mental patients.
- other circumstances that doctors consider inappropriate for the study.
Data sourced from ClinicalTrials.gov (NCT03457909). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.