Trial Outcomes & Findings for MAGNET (Magnetically Controlled Capsule for Assessment of Gastric Mucosa in Symptomatic Patients) (NCT NCT04724291)
NCT ID: NCT04724291
Last Updated: 2023-09-11
Results Overview
Show that MCCE can identify anatomic regions of stomach consistent with established quality metrics for traditional endoscopy (\>90% photo-documentation of pre-established anatomic regions). Each of the 40 MCCE results were reviewed by at least 2 physician reviewers for their ability to document the lower esophagus, Gastroesophageal junction/Z-line, and 6 gastric landmarks the cardia, fundus, body, angularis, antrum, and pylorus.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
90min
Results posted on
2023-09-11
Participant Flow
Adult patients over the age of 18 years old who required an EGD evaluation as part of a standard evaluation of relevant symptoms were approached regarding their willingness to have an MCCE examination. Patients needed to have one of several standard indicators for EGD, and none of the exclusion criteria. Additionally, patients planning on receiving a magnetic resonance imaging exam in the following 30 days were excluded. The study period lasted between February 10, 2021 and June 10, 2022.
There weren't any significant events following participant enrollment, but prior to assignment of participants to an arm or group.
Participant milestones
| Measure |
MCCE(Magnetically Controlled Capsule Endoscopy) & EGD
In this prospective, single-arm, single-center, comparative study, adult patients aged ≥18 years who were referred for an EGD as part of a standard evaluation for symptoms were approached for participation in the study. Participants received MCCE before the EGD. MCCE videos were reviewed by 2 independent physicians and compared with subsequent EGD. Patients were followed for 30 days for safety outcomes and satisfaction.
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MAGNET (Magnetically Controlled Capsule for Assessment of Gastric Mucosa in Symptomatic Patients)
Baseline characteristics by cohort
| Measure |
MCCE(Magnetically Controlled Capsule Endoscopy) & EGD
n=40 Participants
In this prospective, single-arm, single-center, comparative study, adult patients aged ≥18 years who were referred for an EGD as part of a standard evaluation for symptoms were approached for participation in the study. Participants received MCCE before the EGD. MCCE videos were reviewed by 2 independent physicians and compared with subsequent EGD. Patients were followed for 30 days for safety outcomes and satisfaction.
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|---|---|
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Age, Customized
Age ≥ 18
|
40 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
18 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
14 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Race · Other Race
|
7 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=39 Participants
|
|
Medical History
Diabetes mellitus
|
2 participants
n=39 Participants
|
|
Medical History
Kidney failure or on dialysis
|
1 participants
n=39 Participants
|
|
Medical History
Previous smoker/active smoker
|
1 participants
n=39 Participants
|
|
Medical History
Ulcer, gastritis, or acid reflux
|
3 participants
n=39 Participants
|
|
Medical History
Hemorrhoids
|
1 participants
n=39 Participants
|
|
Medical History
Other
|
17 participants
n=39 Participants
|
|
Medical History
None
|
15 participants
n=39 Participants
|
|
Medications
Proton pump inhibitors
|
15 participants
n=39 Participants
|
|
Medications
Nonsteroidal anti-inflammatory drugs
|
7 participants
n=39 Participants
|
|
Reasons for EGD Referral
Low blood (unexplained anemia)
|
5 participants
n=39 Participants
|
|
Reasons for EGD Referral
Upper abdominal or chest pain
|
15 participants
n=39 Participants
|
|
Reasons for EGD Referral
Indigestion (dyspepsia)
|
3 participants
n=39 Participants
|
|
Reasons for EGD Referral
GERD
|
9 participants
n=39 Participants
|
|
Reasons for EGD Referral
Suspected ulcer
|
2 participants
n=39 Participants
|
|
Reasons for EGD Referral
Melena
|
2 participants
n=39 Participants
|
|
Reasons for EGD Referral
Other
|
10 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 90minShow that MCCE can identify anatomic regions of stomach consistent with established quality metrics for traditional endoscopy (\>90% photo-documentation of pre-established anatomic regions). Each of the 40 MCCE results were reviewed by at least 2 physician reviewers for their ability to document the lower esophagus, Gastroesophageal junction/Z-line, and 6 gastric landmarks the cardia, fundus, body, angularis, antrum, and pylorus.
Outcome measures
| Measure |
MCCE(Magnetically Controlled Capsule Endoscopy) & EGD
n=40 Participants
In this prospective, single-arm, single-center, comparative study, adult patients aged ≥18 years who were referred for an EGD as part of a standard evaluation for symptoms were approached for participation in the study. Participants received MCCE before the EGD. MCCE videos were reviewed by 2 independent physicians and compared with subsequent EGD. Patients were followed for 30 days for safety outcomes and satisfaction.
|
|---|---|
|
Number of Participants With Visualization of All Major Anatomic Regions in the Stomach With MCCE Based on 2 Reviewers
Physician Reviewer 1 : No. of cases Cardia was visualized
|
37 participants
|
|
Number of Participants With Visualization of All Major Anatomic Regions in the Stomach With MCCE Based on 2 Reviewers
Physician Reviewer 1 : No. of cases Fundus was visualized
|
39 participants
|
|
Number of Participants With Visualization of All Major Anatomic Regions in the Stomach With MCCE Based on 2 Reviewers
Physician Reviewer 1 : No. of cases Body was visualized
|
39 participants
|
|
Number of Participants With Visualization of All Major Anatomic Regions in the Stomach With MCCE Based on 2 Reviewers
Physician Reviewer 1 : No. of cases Angularis was visualized
|
36 participants
|
|
Number of Participants With Visualization of All Major Anatomic Regions in the Stomach With MCCE Based on 2 Reviewers
Physician Reviewer 1 : No. of cases Antrum was visualized
|
38 participants
|
|
Number of Participants With Visualization of All Major Anatomic Regions in the Stomach With MCCE Based on 2 Reviewers
Physician Reviewer 1 : No. of cases Pylorus was visualized
|
39 participants
|
|
Number of Participants With Visualization of All Major Anatomic Regions in the Stomach With MCCE Based on 2 Reviewers
Physician Reviewer 1 : No. of cases Lower esophagus was visualized
|
39 participants
|
|
Number of Participants With Visualization of All Major Anatomic Regions in the Stomach With MCCE Based on 2 Reviewers
Physician Reviewer 1 : No. of cases gastroesophageal junction/Z-line was visualized
|
31 participants
|
|
Number of Participants With Visualization of All Major Anatomic Regions in the Stomach With MCCE Based on 2 Reviewers
Physician Reviewer 2 : No. of cases Cardia was visualized
|
39 participants
|
|
Number of Participants With Visualization of All Major Anatomic Regions in the Stomach With MCCE Based on 2 Reviewers
Physician Reviewer 2 : No. of cases Fundus was visualized
|
36 participants
|
|
Number of Participants With Visualization of All Major Anatomic Regions in the Stomach With MCCE Based on 2 Reviewers
Physician Reviewer 2 : No. of cases Body was visualized
|
39 participants
|
|
Number of Participants With Visualization of All Major Anatomic Regions in the Stomach With MCCE Based on 2 Reviewers
Physician Reviewer 2 : No. of cases Angularis was visualized
|
39 participants
|
|
Number of Participants With Visualization of All Major Anatomic Regions in the Stomach With MCCE Based on 2 Reviewers
Physician Reviewer 2 : No. of cases Antrum was visualized
|
39 participants
|
|
Number of Participants With Visualization of All Major Anatomic Regions in the Stomach With MCCE Based on 2 Reviewers
Physician Reviewer 2 : No. of cases Pylorus was visualized
|
39 participants
|
|
Number of Participants With Visualization of All Major Anatomic Regions in the Stomach With MCCE Based on 2 Reviewers
Physician Reviewer 2 : No. of cases Lower esophagus was visualized
|
39 participants
|
|
Number of Participants With Visualization of All Major Anatomic Regions in the Stomach With MCCE Based on 2 Reviewers
Physician Reviewer 2 : No. of cases gastroesophageal junction/Z-line was visualized
|
34 participants
|
PRIMARY outcome
Timeframe: 5 DaysThe goal of this assessment was to show that MCC is non-inferior to EGD in detecting both anatomic regions and gastric mucosal lesions
Outcome measures
| Measure |
MCCE(Magnetically Controlled Capsule Endoscopy) & EGD
n=40 Participants
In this prospective, single-arm, single-center, comparative study, adult patients aged ≥18 years who were referred for an EGD as part of a standard evaluation for symptoms were approached for participation in the study. Participants received MCCE before the EGD. MCCE videos were reviewed by 2 independent physicians and compared with subsequent EGD. Patients were followed for 30 days for safety outcomes and satisfaction.
|
|---|---|
|
Comparison to EGD in Identifying Lesions.
no high-risk lesions were missed with MCCE
|
35 Participants
|
|
Comparison to EGD in Identifying Lesions.
patients did not receive a follow-up EGD
|
5 Participants
|
SECONDARY outcome
Timeframe: 30 daysMeasure patient preference for EGD vs MCC with a questionnaire. This will be used to document patient satisfaction from the ingestion of capsule to the 30 day follow-up period.
Outcome measures
| Measure |
MCCE(Magnetically Controlled Capsule Endoscopy) & EGD
n=40 Participants
In this prospective, single-arm, single-center, comparative study, adult patients aged ≥18 years who were referred for an EGD as part of a standard evaluation for symptoms were approached for participation in the study. Participants received MCCE before the EGD. MCCE videos were reviewed by 2 independent physicians and compared with subsequent EGD. Patients were followed for 30 days for safety outcomes and satisfaction.
|
|---|---|
|
Patient Preference Compared to EGD
Patients preferred MCCE
|
31 Participants
|
|
Patient Preference Compared to EGD
Patients preferred EGD
|
3 Participants
|
|
Patient Preference Compared to EGD
Patients had no preference
|
5 Participants
|
|
Patient Preference Compared to EGD
Patients did not answer the question
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 daysMeasure the adverse events after MCC. This will be assessed using a questionnaire which will document any adverse event patient encounters up to the 30 day follow-up.
Outcome measures
| Measure |
MCCE(Magnetically Controlled Capsule Endoscopy) & EGD
n=40 Participants
In this prospective, single-arm, single-center, comparative study, adult patients aged ≥18 years who were referred for an EGD as part of a standard evaluation for symptoms were approached for participation in the study. Participants received MCCE before the EGD. MCCE videos were reviewed by 2 independent physicians and compared with subsequent EGD. Patients were followed for 30 days for safety outcomes and satisfaction.
|
|---|---|
|
Safety of MCC Compared to EGD. Documentation of Any Adverse Event Patient Encounters up to the 30 Day Follow-up.
No adverse outcome reported
|
39 Participants
|
|
Safety of MCC Compared to EGD. Documentation of Any Adverse Event Patient Encounters up to the 30 Day Follow-up.
Adverse outcome reported
|
0 Participants
|
|
Safety of MCC Compared to EGD. Documentation of Any Adverse Event Patient Encounters up to the 30 Day Follow-up.
Did not respond
|
1 Participants
|
Adverse Events
MCCE(Magnetically Controlled Capsule Endoscopy) & EGD
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place