Trial Outcomes & Findings for Comparative Study of MCCE With/Without Tether vs Conventional Upper Endoscopy in Patients With Upper Abdominal Symptoms (NCT NCT04605302)
NCT ID: NCT04605302
Last Updated: 2026-05-27
Results Overview
A count of the cumulative total number of lesions identified by the MCCE procedure versus a count of the cumulative total number of lesions identified by the EGD procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
Day of EGD procedure
Results posted on
2026-05-27
Participant Flow
11 healthy volunteers had the MCCE procedure for training purposes only, they did not have the EGD procedure; demographic data was collected, however outcome data was not collected or analyzed
Participant milestones
| Measure |
Single Arm Tandem Procedures
Participants undergo two consecutive endoscopy procedures - magnetically controlled capsule endoscopy (MCCE) and esophagogastroduodenoscopy (EGD).
|
Healthy Volunteers
Healthy volunteers received the MCC procedure only for training purposes. Demographic data was collected, but they did not have the EGD procedure and there is no outcome data or analysis.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
11
|
|
Overall Study
COMPLETED
|
16
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Study of MCCE With/Without Tether vs Conventional Upper Endoscopy in Patients With Upper Abdominal Symptoms
Baseline characteristics by cohort
| Measure |
Single Arm Tandem Procedures
n=16 Participants
Participants undergo two consecutive endoscopy procedures - magnetically controlled capsule endoscopy (MCCE) and esophagogastroduodenoscopy (EGD).
|
Healthy Volunteers
n=11 Participants
Healthy volunteers had the MCC procedure for training purposes only. Demographics data was captured, but follow up data was not recorded and outcome data was not analyzed.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.25 years
STANDARD_DEVIATION 13.77 • n=51 Participants
|
52.45 years
STANDARD_DEVIATION 7.90 • n=14 Participants
|
50.56 years
STANDARD_DEVIATION 11.66 • n=65 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=51 Participants
|
7 Participants
n=14 Participants
|
16 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=51 Participants
|
4 Participants
n=14 Participants
|
11 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
2 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=51 Participants
|
11 Participants
n=14 Participants
|
22 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
3 Participants
n=65 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=51 Participants
|
2 Participants
n=14 Participants
|
2 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=51 Participants
|
9 Participants
n=14 Participants
|
24 Participants
n=65 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Population
|
16 Participants
n=51 Participants
|
11 Participants
n=14 Participants
|
27 Participants
n=65 Participants
|
PRIMARY outcome
Timeframe: Day of EGD procedureA count of the cumulative total number of lesions identified by the MCCE procedure versus a count of the cumulative total number of lesions identified by the EGD procedure.
Outcome measures
| Measure |
Single Arm Tandem Study
n=16 Participants
Participants undergo two consecutive endoscopy procedures - magnetically controlled capsule endoscopy (MCCE) and esophagogastroduodenoscopy (EGD).
|
EGD Procedure
n=16 Participants
Participants who had the esophagogastroduodenoscopy (EGD) procedure
|
|---|---|---|
|
Compare Total Number of Lesions Identified Via MCCE Versus EGD
|
10 # of lesions identified
|
12 # of lesions identified
|
PRIMARY outcome
Timeframe: 24-72 hour follow up phone call post EGD procedurePopulation: interventional group
Occurrence and severity of adverse event related to MCCE procedure versus EGD procedure. Outcomes noted in AE/SAE sections. Adverse Events were NOT collected in the Healthy Volunteer arm.
Outcome measures
| Measure |
Single Arm Tandem Study
n=16 Participants
Participants undergo two consecutive endoscopy procedures - magnetically controlled capsule endoscopy (MCCE) and esophagogastroduodenoscopy (EGD).
|
EGD Procedure
Participants who had the esophagogastroduodenoscopy (EGD) procedure
|
|---|---|---|
|
Number of Adverse Events
# of AEs identified with MCC
|
1 events
|
—
|
|
Number of Adverse Events
# of AEs identified with EGD
|
2 events
|
—
|
SECONDARY outcome
Timeframe: 24-72 hour follow up phone call post EGD procedurePopulation: Participants who received both MCCE and EGD
Participant acceptance of MCCE versus EGD (units on a scale, scale of 1 to 10; when 1 is the lowest and 10 is the highest score)
Outcome measures
| Measure |
Single Arm Tandem Study
n=16 Participants
Participants undergo two consecutive endoscopy procedures - magnetically controlled capsule endoscopy (MCCE) and esophagogastroduodenoscopy (EGD).
|
EGD Procedure
Participants who had the esophagogastroduodenoscopy (EGD) procedure
|
|---|---|---|
|
Participant Satisfaction Score With MCCE Procedure Versus EGD Procedure
Satisfaction with MCCE procedure
|
8.13 units on a scale
Standard Deviation 2.33
|
—
|
|
Participant Satisfaction Score With MCCE Procedure Versus EGD Procedure
Satisfaction with EGD procedure
|
7.56 units on a scale
Standard Deviation 2.66
|
—
|
SECONDARY outcome
Timeframe: Day of procedurePopulation: All 16 participants completed both the MCC and the EGC procedure.
Total count of participants who were able to complete their MCC procedure, compared to a total count of participants able to complete their EGD procedure.
Outcome measures
| Measure |
Single Arm Tandem Study
n=16 Participants
Participants undergo two consecutive endoscopy procedures - magnetically controlled capsule endoscopy (MCCE) and esophagogastroduodenoscopy (EGD).
|
EGD Procedure
n=16 Participants
Participants who had the esophagogastroduodenoscopy (EGD) procedure
|
|---|---|---|
|
To Compare Rate of Complete Examination for the MCC and EGD Procedures
|
16 participants
|
16 participants
|
Adverse Events
Single Arm Tandem Procedures
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Arm Tandem Procedures
n=16 participants at risk
Participants undergo two consecutive endoscopy procedures - magnetically controlled capsule endoscopy (MCCE) and esophagogastroduodenoscopy (EGD).
Healthy volunteers assisted with physician training and received the capsule endoscopy only, they did not have the EGD procedure. Healthy volunteers were NOT followed for Adverse Event or Follow-up Data.
|
|---|---|
|
Gastrointestinal disorders
abdominal cramping with MCCE procedure
|
33.3%
1/3 • Number of events 1 • Participants were followed in this study for 24-72 hours post the EGD procedure. Any open AEs to be followed by the prescribing physician.
subcategories = mild vs moderate vs severe
|
|
Gastrointestinal disorders
vomiting with EGD procedure
|
6.2%
1/16 • Number of events 1 • Participants were followed in this study for 24-72 hours post the EGD procedure. Any open AEs to be followed by the prescribing physician.
subcategories = mild vs moderate vs severe
|
|
Gastrointestinal disorders
acid reflux with EGD procedure
|
6.2%
1/16 • Number of events 1 • Participants were followed in this study for 24-72 hours post the EGD procedure. Any open AEs to be followed by the prescribing physician.
subcategories = mild vs moderate vs severe
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place