Trial Outcomes & Findings for A Study to Evaluate Safety and Effectiveness of G-POEM for Gastroparesis (NCT NCT04869670)
NCT ID: NCT04869670
Last Updated: 2026-05-22
Results Overview
The effect of GPOEM on nausea, early satiety, postprandial fullness, and upper abdominal pain as per changes in patient scoring in The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) which has been designed to assess symptoms associated with gastroparesis. ANMS GCSI-DD evaluates five core symptoms: nausea, bloating, upper abdominal pain, stomach fullness and inability to finish a meal. Each symptom is rated 0-4 with 0= none, 1= mild, 2= moderate, 3= severe, and 4= very severe. The five responses are summed and divided by the number of responses completed to compute a total mean score range from 0-4, with higher scores indicating worse symptoms.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
Baseline to 48 weeks post treatment
Results posted on
2026-05-22
Participant Flow
Protocol enrollment includes all participants who consented and entered screening. Three participants were enrolled in the study, one of which screen failed prior to randomization.
Participant milestones
| Measure |
G-POEM
Gastric peroral endoscopic myotomy.: Under propofol anesthesia, EndoFLIP will be used to assess pyloric diameter and distensibility, prior to and after G-POEM, performed by an endoscopist skilled in this technique. After the procedure, the patient will be observed in the hospital for 2 days. Patients will undergo an upper GI series the next day to rule out perforation. If the patient develops a complication from the procedure, he or she will be managed per standard clinical practice by the treating (unblinded) endoscopist.
|
Sham Procedure
Sham Gastric peroral endoscopic myotomy.: Patients assigned to the sham procedure will be treated identically as above, except for the performance of the G-POEM. Endoscopy and EndoFLIP will be performed and sedation will be stopped when the upper endoscopy is completed. Since sham endoscopy is expected to take less time than G-POEM, the patient should remain in the endoscopy procedure room for a minimum of 30 minutes (including the time required to complete the upper endoscopy). After the procedure, the patient will be observed in the hospital for 2 days. All patients will undergo an upper GI series radiographic examination the next day to rule out perforation in order to maintain study blind.
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|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
G-POEM
Gastric peroral endoscopic myotomy.: Under propofol anesthesia, EndoFLIP will be used to assess pyloric diameter and distensibility, prior to and after G-POEM, performed by an endoscopist skilled in this technique. After the procedure, the patient will be observed in the hospital for 2 days. Patients will undergo an upper GI series the next day to rule out perforation. If the patient develops a complication from the procedure, he or she will be managed per standard clinical practice by the treating (unblinded) endoscopist.
|
Sham Procedure
Sham Gastric peroral endoscopic myotomy.: Patients assigned to the sham procedure will be treated identically as above, except for the performance of the G-POEM. Endoscopy and EndoFLIP will be performed and sedation will be stopped when the upper endoscopy is completed. Since sham endoscopy is expected to take less time than G-POEM, the patient should remain in the endoscopy procedure room for a minimum of 30 minutes (including the time required to complete the upper endoscopy). After the procedure, the patient will be observed in the hospital for 2 days. All patients will undergo an upper GI series radiographic examination the next day to rule out perforation in order to maintain study blind.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate Safety and Effectiveness of G-POEM for Gastroparesis
Baseline characteristics by cohort
| Measure |
G-POEM
n=2 Participants
Gastric peroral endoscopic myotomy.: Under propofol anesthesia, EndoFLIP will be used to assess pyloric diameter and distensibility, prior to and after G-POEM, performed by an endoscopist skilled in this technique. After the procedure, the patient will be observed in the hospital for 2 days. Patients will undergo an upper GI series the next day to rule out perforation. If the patient develops a complication from the procedure, he or she will be managed per standard clinical practice by the treating (unblinded) endoscopist.
|
Sham Procedure
Sham Gastric peroral endoscopic myotomy.: Patients assigned to the sham procedure will be treated identically as above, except for the performance of the G-POEM. Endoscopy and EndoFLIP will be performed and sedation will be stopped when the upper endoscopy is completed. Since sham endoscopy is expected to take less time than G-POEM, the patient should remain in the endoscopy procedure room for a minimum of 30 minutes (including the time required to complete the upper endoscopy). After the procedure, the patient will be observed in the hospital for 2 days. All patients will undergo an upper GI series radiographic examination the next day to rule out perforation in order to maintain study blind.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 14.5 • n=2 Participants
|
—
|
39 years
STANDARD_DEVIATION 14.5 • n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=2 Participants
|
—
|
2 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline to 48 weeks post treatmentPopulation: Due to low enrollment, zero subjects were enrolled in the sham arm of the study.
The effect of GPOEM on nausea, early satiety, postprandial fullness, and upper abdominal pain as per changes in patient scoring in The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) which has been designed to assess symptoms associated with gastroparesis. ANMS GCSI-DD evaluates five core symptoms: nausea, bloating, upper abdominal pain, stomach fullness and inability to finish a meal. Each symptom is rated 0-4 with 0= none, 1= mild, 2= moderate, 3= severe, and 4= very severe. The five responses are summed and divided by the number of responses completed to compute a total mean score range from 0-4, with higher scores indicating worse symptoms.
Outcome measures
| Measure |
G-POEM
n=1 Participants
Gastric peroral endoscopic myotomy.: Under propofol anesthesia, EndoFLIP will be used to assess pyloric diameter and distensibility, prior to and after G-POEM, performed by an endoscopist skilled in this technique. After the procedure, the patient will be observed in the hospital for 2 days. Patients will undergo an upper GI series the next day to rule out perforation. If the patient develops a complication from the procedure, he or she will be managed per standard clinical practice by the treating (unblinded) endoscopist.
|
Sham Procedure
Sham Gastric peroral endoscopic myotomy.: Patients assigned to the sham procedure will be treated identically as above, except for the performance of the G-POEM. Endoscopy and EndoFLIP will be performed and sedation will be stopped when the upper endoscopy is completed. Since sham endoscopy is expected to take less time than G-POEM, the patient should remain in the endoscopy procedure room for a minimum of 30 minutes (including the time required to complete the upper endoscopy). After the procedure, the patient will be observed in the hospital for 2 days. All patients will undergo an upper GI series radiographic examination the next day to rule out perforation in order to maintain study blind.
|
|---|---|---|
|
GCSI-DD Change
Baseline
|
2.5 score on a scale
|
—
|
|
GCSI-DD Change
Week 48 post-treatment
|
0.3 score on a scale
|
—
|
SECONDARY outcome
Timeframe: Baseline to 48 weeks post treatmentPopulation: Due to low enrollment, zero subjects were enrolled in the sham arm of the study.
The effect of GPOEM on quality of life assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QoL). The PAGI-QOL instrument consists of 30 items, each with response options based on a 6-point scale ranging from 0 (lowest QoL) to 5 (highest QoL) and with a recall period of the previous 2 weeks. The items are grouped into 5 dimensions: Daily Activities, Clothing, Diet and Food Habits, Relationship and Psychological Well-being and Distress. The 30 responses are summed and divided by the number of responses completed to compute a total mean score range of 0 to 5, with higher scores indicating better quality of life.
Outcome measures
| Measure |
G-POEM
n=1 Participants
Gastric peroral endoscopic myotomy.: Under propofol anesthesia, EndoFLIP will be used to assess pyloric diameter and distensibility, prior to and after G-POEM, performed by an endoscopist skilled in this technique. After the procedure, the patient will be observed in the hospital for 2 days. Patients will undergo an upper GI series the next day to rule out perforation. If the patient develops a complication from the procedure, he or she will be managed per standard clinical practice by the treating (unblinded) endoscopist.
|
Sham Procedure
Sham Gastric peroral endoscopic myotomy.: Patients assigned to the sham procedure will be treated identically as above, except for the performance of the G-POEM. Endoscopy and EndoFLIP will be performed and sedation will be stopped when the upper endoscopy is completed. Since sham endoscopy is expected to take less time than G-POEM, the patient should remain in the endoscopy procedure room for a minimum of 30 minutes (including the time required to complete the upper endoscopy). After the procedure, the patient will be observed in the hospital for 2 days. All patients will undergo an upper GI series radiographic examination the next day to rule out perforation in order to maintain study blind.
|
|---|---|---|
|
Change in Quality of Life as Assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life Scale
Baseline
|
3.73 score on a scale
|
—
|
|
Change in Quality of Life as Assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life Scale
48 weeks post-treatment
|
0.83 score on a scale
|
—
|
Adverse Events
G-POEM
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham Procedure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
G-POEM
n=2 participants at risk
Gastric peroral endoscopic myotomy.: Under propofol anesthesia, EndoFLIP will be used to assess pyloric diameter and distensibility, prior to and after G-POEM, performed by an endoscopist skilled in this technique. After the procedure, the patient will be observed in the hospital for 2 days. Patients will undergo an upper GI series the next day to rule out perforation. If the patient develops a complication from the procedure, he or she will be managed per standard clinical practice by the treating (unblinded) endoscopist.
|
Sham Procedure
Sham Gastric peroral endoscopic myotomy.: Patients assigned to the sham procedure will be treated identically as above, except for the performance of the G-POEM. Endoscopy and EndoFLIP will be performed and sedation will be stopped when the upper endoscopy is completed. Since sham endoscopy is expected to take less time than G-POEM, the patient should remain in the endoscopy procedure room for a minimum of 30 minutes (including the time required to complete the upper endoscopy). After the procedure, the patient will be observed in the hospital for 2 days. All patients will undergo an upper GI series radiographic examination the next day to rule out perforation in order to maintain study blind.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from the date of the study procedure through the 48-week follow-up period.
Adverse events (AEs) were defined as any unfavorable medical occurrence, including abnormal laboratory findings, temporally associated with study participation, regardless of causality. Serious adverse events (SAEs) included death, life-threatening events, hospitalization, disability, or other medically important events. AEs were collected through participant report, clinical evaluation, and laboratory assessment, and graded per CTCAE v4.0 when applicable.
|
—
0/0 • Adverse events were collected from the date of the study procedure through the 48-week follow-up period.
Adverse events (AEs) were defined as any unfavorable medical occurrence, including abnormal laboratory findings, temporally associated with study participation, regardless of causality. Serious adverse events (SAEs) included death, life-threatening events, hospitalization, disability, or other medically important events. AEs were collected through participant report, clinical evaluation, and laboratory assessment, and graded per CTCAE v4.0 when applicable.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place