Trial Outcomes & Findings for Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric Motility (NCT NCT05004012)
NCT ID: NCT05004012
Last Updated: 2026-04-29
Results Overview
Physiologic parameter measuring the frequency and direction of stomach contractions at baseline (before sham meal).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Comparison between stomach contractions at baseline (Stage 1/ before sham meal)
Results posted on
2026-04-29
Participant Flow
Participant milestones
| Measure |
Control
No diagnosis of gastroparesis, functional dyspepsia, or prior G-POEM
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
Gastroparesis
Patients with a diagnosis of gastroparesis meeting the inclusion criteria
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
Functional Dyspepsia
Patients with a diagnosis of functional dyspepsia meeting the inclusion criteria
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
G-POEM
Patients who received a G-POEM procedure meeting the inclusion criteria
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
6
|
0
|
|
Overall Study
COMPLETED
|
6
|
5
|
6
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric Motility
Baseline characteristics by cohort
| Measure |
G-POEM
Patients who received a G-POEM procedure meeting the inclusion criteria
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
Total
n=17 Participants
Total of all reporting groups
|
Control
n=6 Participants
No diagnosis of gastroparesis, functional dyspepsia, or prior G-POEM
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
Gastroparesis
n=5 Participants
Patients with a diagnosis of gastroparesis meeting the inclusion criteria
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
Functional Dyspepsia
n=6 Participants
Patients with a diagnosis of functional dyspepsia meeting the inclusion criteria
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
|---|---|---|---|---|---|
|
Age, Continuous
|
—
|
34.3 years
STANDARD_DEVIATION 10.3 • n=451 Participants
|
33.3 years
STANDARD_DEVIATION 10 • n=9 Participants
|
36 years
STANDARD_DEVIATION 14 • n=24 Participants
|
33.8 years
STANDARD_DEVIATION 6.6 • n=23 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=73 Participants
|
13 Participants
n=451 Participants
|
3 Participants
n=9 Participants
|
4 Participants
n=24 Participants
|
6 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=73 Participants
|
4 Participants
n=451 Participants
|
3 Participants
n=9 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
3 Participants
n=451 Participants
|
0 Participants
n=9 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
14 Participants
n=451 Participants
|
6 Participants
n=9 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=451 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
PRIMARY outcome
Timeframe: Comparison between stomach contractions at baseline (Stage 1/ before sham meal)Population: no G-POEM patients were enrolled so no data was analyzed
Physiologic parameter measuring the frequency and direction of stomach contractions at baseline (before sham meal).
Outcome measures
| Measure |
Control
n=6 Participants
No diagnosis of gastroparesis, functional dyspepsia, or prior G-POEM
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
Gastroparesis
n=5 Participants
Patients with a diagnosis of gastroparesis meeting the inclusion criteria
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
Functional Dyspepsia
n=5 Participants
Patients with a diagnosis of functional dyspepsia meeting the inclusion criteria
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
G-POEM
Patients who received a G-POEM procedure meeting the inclusion criteria
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
|---|---|---|---|---|
|
Frequency of Contractions at Baseline
|
20 stomach contractions/minute
Interval 16.84 to 23.16
|
24.6 stomach contractions/minute
Interval 19.8 to 29.4
|
23.7 stomach contractions/minute
Interval 19.55 to 27.85
|
—
|
PRIMARY outcome
Timeframe: assessed after the sham meal (stage II, completed within 2 hours of baseline)Population: no G-POEM enrolled
Physiologic parameter measuring the diameter of the pylorus
Outcome measures
| Measure |
Control
n=6 Participants
No diagnosis of gastroparesis, functional dyspepsia, or prior G-POEM
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
Gastroparesis
n=5 Participants
Patients with a diagnosis of gastroparesis meeting the inclusion criteria
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
Functional Dyspepsia
n=5 Participants
Patients with a diagnosis of functional dyspepsia meeting the inclusion criteria
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
G-POEM
Patients who received a G-POEM procedure meeting the inclusion criteria
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
|---|---|---|---|---|
|
Largest Diameter of the Pylorus
|
10.20 millimeters
Standard Deviation 5.25
|
13.40 millimeters
Standard Deviation 3.04
|
9.38 millimeters
Standard Deviation 5.61
|
—
|
PRIMARY outcome
Timeframe: Assessed at baseline.Population: no G-POEM enrolled. Data were not collected for the "Control" Arm/Group since these participants did not display symptoms of dyspepsia
Evaluating the dyspepsia Severity Scale symptom ratings (range of score 0-20; with higher scores indicating more severe symptoms of dyspepsia) at baseline.
Outcome measures
| Measure |
Control
No diagnosis of gastroparesis, functional dyspepsia, or prior G-POEM
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
Gastroparesis
n=5 Participants
Patients with a diagnosis of gastroparesis meeting the inclusion criteria
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
Functional Dyspepsia
n=5 Participants
Patients with a diagnosis of functional dyspepsia meeting the inclusion criteria
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
G-POEM
Patients who received a G-POEM procedure meeting the inclusion criteria
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
|---|---|---|---|---|
|
Dyspepsia Severity Scale Symptom Ratings at Baseline.
|
—
|
10.8 score on a scale from 0-20
Standard Deviation 8.2
|
3.5 score on a scale from 0-20
Standard Deviation 2.2
|
—
|
PRIMARY outcome
Timeframe: Through participants' study participation, approximately 1 dayPopulation: no G-POEM patients were able to be enrolled
Procedure related adverse events during or after the study session
Outcome measures
| Measure |
Control
n=6 Participants
No diagnosis of gastroparesis, functional dyspepsia, or prior G-POEM
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
Gastroparesis
n=5 Participants
Patients with a diagnosis of gastroparesis meeting the inclusion criteria
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
Functional Dyspepsia
n=5 Participants
Patients with a diagnosis of functional dyspepsia meeting the inclusion criteria
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
G-POEM
Patients who received a G-POEM procedure meeting the inclusion criteria
Magnetically Controlled Capsule Endoscopy: This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
|
|---|---|---|---|---|
|
Number of Participants With Procedure Related Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of 1 yearMeasurement of the Number and Location of Luminal Transit Markers in the Antrum, Fundus, and Overall.
Outcome measures
Outcome data not reported
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gastroparesis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Functional Dyspepsia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
G-POEM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lin Chang MD (PI), regan cortessis (study coordinator)
UCLA
Phone: 310-206-1656
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place