N/A
N=80
The Second-Generation MCCG for Upper Gastrointestinal Tract.
Capsule Endoscopy
Bottom Line
View on ClinicalTrials.gov: NCT03977935 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Circumferential Visualization of the Z-line — 0; 5; 5; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- the second-generation MCCG (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Changhai Hospital
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Circumferential Visualization of the Z-line |
0; 5; 5; 7; 12; 12 | — |
| SECONDARY Detection Rate of Duodenal Papilla |
3; 6 | — |
| SECONDARY Gastric Examination Time (GET) |
7.78; 5.24 | — |
| SECONDARY Manipulation Performance Score of the MCCG |
3.04; 4.59; 3.16; 4.51; 3.84; 4.17 | — |
| SECONDARY Image Quality Score (Mainly Focus on Clarity) |
7.90; 8.63 | — |
| SECONDARY The Number of Images Captured for Esophagus and Z-line |
97; 171; 0; 2 | — |
| SECONDARY Number of Participants With Lesions in Upper Gastrointestinal Tract |
25; 24; 12; 13; 3; 3 | — |
| SECONDARY Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time |
53.09; 48.35; 327.60; 297.22; 702.83; 1001.99 | — |
| SECONDARY Cleansing Level Score of Z-line Area |
13; 11; 18; 22; 7; 5 | — |
| SECONDARY The Incidence of Adverse Events (The Safety of MCCG) |
0; 0 | — |
| SECONDARY Transit Time of MCCG in Esophagus |
59.5; 44.5 | — |
Summary
The aim of this study is to evaluate the clinical application of the second-generation MCCG with higher image resolution and frame rate for upper gastrointestinal tract compared with the first-generation.
Eligibility Criteria
Inclusion Criteria
- With or without gastrointestinal complaints
- Scheduled to undergo a capsule endoscopy for both stomach and small bowel
- Signed the informed consents before joining this study
Exclusion Criteria
- Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy
- Refused abdominal surgery to take out the capsule in case of capsule retention
- Implanted pacemaker, except the pacemaker is compatible with MRI
- Other implanted electromedical devices or magnetic metal foreign bodies
- Pregnancy or suspected pregnancy
Data sourced from ClinicalTrials.gov (NCT03977935). 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.