Trial Outcomes & Findings for Body Surface Gastric Mapping vs Gastric Emptying Scintigraphy on Clinical Management in Gastroparesis (NCT NCT06411574)
NCT ID: NCT06411574
Last Updated: 2026-08-31
Results Overview
In phase 1, the change in clinical management decisions from the single test result to the combined test results was assessed. For each arm, the proportion of patients with a management change is reported as a percentage. In the first plan (either unblinded to BSGM or GES first), a management change was defined as any addition, removal or modification within a category (eg, switching from 1 prokinetic to another) compared to the initial management plan. In the second plan (unblinded to both test results), a change due to the combined test results was defined as any addition, removal or modification within the same category compared to the first plan. The categories were: medication, diet, psychology-based interventions, surgery referral, other intervention and additional testing.
COMPLETED
NA
16 participants
After unblinding to first test (week 1) and after unblinding to second test (week 2)
2026-08-31
Participant Flow
Patients aged ≥ 18 years old and referred to GES for evaluation of their chronic gastroduodenal symptoms were recruited from a tertiary center.
Participant milestones
| Measure |
Phase 1: Unblinded to GES First Then Unblinded to BSGM
A management plan was devised based on the GES results first, and then the management plan was updated after reviewing the BSGM results.
|
Phase 1: Unblinded to BSGM First Then Unblinded to GES
A management plan was devised based on the BSGM results first, and then the management plan was updated after reviewing the GES results.
|
Phase 2: BSGM-guided Care (Participants From Phase 1 Only)
Those in Phase 1 will undergo BSGM-guided care based on their combined management plan (GES + BSGM) and followed up over a 12 month period.
|
Phase 2: Standard of Care
A separate set of patients as part of Phase 2 will be recruited to undergo standard of care (GES only) and followed up over 6 months. After 6 months, patients will be given the option to be crossed over to BSGM-guided care, undergo a BSGM test, treated according to the new management plan, and followed up over 6 months.
|
|---|---|---|---|---|
|
Phase 1
STARTED
|
8
|
8
|
0
|
0
|
|
Phase 1
COMPLETED
|
8
|
8
|
0
|
0
|
|
Phase 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase 2
STARTED
|
0
|
0
|
16
|
0
|
|
Phase 2
COMPLETED
|
0
|
0
|
3
|
0
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
13
|
0
|
Reasons for withdrawal
| Measure |
Phase 1: Unblinded to GES First Then Unblinded to BSGM
A management plan was devised based on the GES results first, and then the management plan was updated after reviewing the BSGM results.
|
Phase 1: Unblinded to BSGM First Then Unblinded to GES
A management plan was devised based on the BSGM results first, and then the management plan was updated after reviewing the GES results.
|
Phase 2: BSGM-guided Care (Participants From Phase 1 Only)
Those in Phase 1 will undergo BSGM-guided care based on their combined management plan (GES + BSGM) and followed up over a 12 month period.
|
Phase 2: Standard of Care
A separate set of patients as part of Phase 2 will be recruited to undergo standard of care (GES only) and followed up over 6 months. After 6 months, patients will be given the option to be crossed over to BSGM-guided care, undergo a BSGM test, treated according to the new management plan, and followed up over 6 months.
|
|---|---|---|---|---|
|
Phase 2
Lost to Follow-up
|
0
|
0
|
13
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Phase 1: Unblinded to GES First Then Unblinded to BSGM
n=8 Participants
A management plan was devised based on the GES results first, and then the management plan was updated after reviewing the BSGM results.
|
Phase 1: Unblinded to BSGM First Then Unblinded to GES
n=8 Participants
A management plan was devised based on the BSGM results first, and then the management plan was updated after reviewing the GES results.
|
Phase 2: BSGM-guided Care (Participants From Phase 1 Only)
n=16 Participants
Those in Phase 1 will undergo BSGM-guided care based on their combined management plan (GES + BSGM) and followed up over a 12 month period.
|
Phase 2: Standard of Care
A separate set of patients as part of Phase 2 will be recruited to undergo standard of care (GES only) and followed up over 6 months. After 6 months, patients will be given the option to be crossed over to BSGM-guided care, undergo a BSGM test, treated according to the new management plan, and followed up over 6 months.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49 Years
n=8 Participants
|
23 Years
n=8 Participants
|
30 Years
n=16 Participants
|
—
|
30 Years
n=32 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
13 Participants
n=16 Participants
|
0 Participants
|
26 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=16 Participants
|
0 Participants
|
6 Participants
n=32 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: After unblinding to first test (week 1) and after unblinding to second test (week 2)Population: This outcome measure was pre-specified to evaluate endpoints exclusively during Phase 1. Data for this measure were not collected during Phase 2, as this follow-up phase did not include assessments for this specific outcome measure.
In phase 1, the change in clinical management decisions from the single test result to the combined test results was assessed. For each arm, the proportion of patients with a management change is reported as a percentage. In the first plan (either unblinded to BSGM or GES first), a management change was defined as any addition, removal or modification within a category (eg, switching from 1 prokinetic to another) compared to the initial management plan. In the second plan (unblinded to both test results), a change due to the combined test results was defined as any addition, removal or modification within the same category compared to the first plan. The categories were: medication, diet, psychology-based interventions, surgery referral, other intervention and additional testing.
Outcome measures
| Measure |
Phase 1: Unblinded to GES First
n=8 Participants
A management plan was devised based on the GES results first.
|
Phase 1: Unblinded to BSGM Second
n=8 Participants
For those unblinded to GES first, the management plan was updated after reviewing the BSGM results.
|
Phase 1: Unblinded to BSGM First
n=8 Participants
A management plan was devised based on the BSGM results first.
|
Phase 1: Unblinded to GES Second.
n=8 Participants
For those unblinded to BSGM first, the management plan was updated after reviewing the GES results.
|
|---|---|---|---|---|
|
Phase 1: Change in Clinical Management Decisions Based on the Combined Test Results Compared to the Single Test Result.
|
8 Participants
|
6 Participants
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: After unblinding to first test (week 1) and after unblinding to second test (week 2)Population: This outcome measure was pre-specified to evaluate endpoints exclusively during Phase 1. Data for this measure were not collected during Phase 2, as this follow-up phase did not include assessments for this specific outcome measure.
In phase 1, a change in diagnosis was defined as either an addition of a diagnosis or a shift to a different one compared to baseline (confirmation of an existing diagnosis was not considered a change).
Outcome measures
| Measure |
Phase 1: Unblinded to GES First
n=16 Participants
A management plan was devised based on the GES results first.
|
Phase 1: Unblinded to BSGM Second
n=16 Participants
For those unblinded to GES first, the management plan was updated after reviewing the BSGM results.
|
Phase 1: Unblinded to BSGM First
A management plan was devised based on the BSGM results first.
|
Phase 1: Unblinded to GES Second.
For those unblinded to BSGM first, the management plan was updated after reviewing the GES results.
|
|---|---|---|---|---|
|
Phase 1: Change to a Single Clinical Diagnosis Due to the Combined Test Results From Baseline.
|
2 Participants
|
8 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: After unblinding to first test (week 1) and after unblinding to second test (week 2)Population: This outcome measure was pre-specified to evaluate endpoints exclusively during Phase 1. Data for this measure were not collected during Phase 2, as this follow-up phase did not include assessments for this specific outcome measure.
In phase 1, Clinicians rated diagnostic and management plan certainty using a Likert scale (0-10; 0 = uncertain, 10 = certain) firstly after reviewing the initial allocated test (GES or BSGM) and formulating the first management plan with a single test result, and again after reviewing the second test and formulating the second management plan with the combined test results. The change in the certainty score from the single test result to the combined test results was assessed.
Outcome measures
| Measure |
Phase 1: Unblinded to GES First
n=8 Participants
A management plan was devised based on the GES results first.
|
Phase 1: Unblinded to BSGM Second
n=8 Participants
For those unblinded to GES first, the management plan was updated after reviewing the BSGM results.
|
Phase 1: Unblinded to BSGM First
n=8 Participants
A management plan was devised based on the BSGM results first.
|
Phase 1: Unblinded to GES Second.
n=8 Participants
For those unblinded to BSGM first, the management plan was updated after reviewing the GES results.
|
|---|---|---|---|---|
|
Phase 1: Change in Clinician Certainty Based on the Combined Test Results Compared to a Single Test Result
Management plan certainty
|
6.0 Score
Interval 5.0 to 6.3
|
7.5 Score
Interval 6.0 to 8.0
|
5.0 Score
Interval 3.5 to 6.3
|
6.5 Score
Interval 5.8 to 7.0
|
|
Phase 1: Change in Clinician Certainty Based on the Combined Test Results Compared to a Single Test Result
Diagnostic certainty
|
6.5 Score
Interval 5.8 to 8.0
|
8.0 Score
Interval 7.8 to 9.0
|
5.0 Score
Interval 3.0 to 7.3
|
8.0 Score
Interval 7.8 to 9.0
|
Adverse Events
Phase 1: Unblinded to GES First Then Unblinded to BSGM
Phase 1: Unblinded to BSGM First Then Unblinded to GES
Phase 2: BSGM-guided Care (Participants From Phase 1 Only)
Phase 2: Standard of Care
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