A Study to Evaluate Safety and Effectiveness of G-POEM fo... | NCT04869670

NCT04869670

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
R01DK125680	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
Johns Hopkins University	OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Arms/Interventions Module

Label	Type	Description	Intervention Names
G-POEM	Experimental		Procedure: Gastric peroral endoscopic myotomy.
Sham procedure	Sham Comparator		Procedure: Sham Gastric peroral endoscopic myotomy.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gastric peroral endoscopic myotomy.	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
GCSI-DD Change	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.	Baseline to 48 weeks post treatment

Secondary Outcomes

Measure	Description	Time Frame
Change in Quality of Life as Assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life Scale	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptoms of chronic nausea or vomiting compatible with gastroparesis (idiopathic or diabetic) must be present for at least one year (does not have to be contiguous) prior to registration.
Must have a mean total Gastroparesis Cardinal Symptom Index (GCSI) score of ≥ 3 at screening visit.
Refractory gastroparesis, defined using our previously published data5, as a failure to improve over the last 6 months, despite an adequate trial of one or more standard prokinetics (metoclopramide, erythromycin, prucalopride), antinauseants (5-HT3 antagonists, promethazine, prochlorperazine, dronabinol), or neuromodulators (mirtazapine, buspirone).
Moderate to severe delay in gastric emptying, defined as > 25% solid retained at 4 hours or > 75% retained at 2 hours. The qualifying gastric emptying scintigraphy must be performed within 18 months prior to registration or can be the baseline gastric emptying.
No evidence of mechanical obstruction based on upper GI endoscopy or upper GI series in their medical history.

Exclusion Criteria:

Another active disorder which could explain symptoms in the opinion of the investigator.
Gastric retention of solids at 4 hours < 25% or < 75% at 2 hours.
Ongoing use of prokinetic agents (e.g., metoclopramide, erythromycin, prucalopride) GLP -1 analog or agonists, or drugs that slow down gastric emptying (narcotics). Neuromodulators such as tricyclic antidepressants (amitriptyline or nortriptyline) or others that are being used at stable doses for a month prior to randomization may continue at the discretion of the care provider.
Significant systemic illness such as chronic renal failure (adjusted for age) or liver disease as defined by Child-Pugh score of 10 or greater.
Poorly controlled diabetes with HbA1c of greater than 10% at time of screening.
New medications for gastroparesis-related symptoms started within 1 month prior to registration.
Pregnancy or nursing.
Failure to give informed consent.
Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study.
Botox injection into the pylorus within 3 months prior to registration.
Allergy to eggs or Egg Beaters and Ensure.

Name	Affiliation	Role
Michael Camilleri, MD	Mayo Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Arizona		Scottsdale	Arizona	85259	United States
Mayo Clinic

Label	URL
Mayo Clinic Clinical Trials	View source

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

GCSI-DD Change

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.

Due to low enrollment, zero subjects were enrolled in the sham arm of the study.

Posted

Number

score on a scale

Baseline to 48 weeks post treatment

ID	Title	Description
OG000	G-POEM

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nausea	Gastrointestinal disorders		Non-systematic Assessment

Title	Organization	Phone	Extension	Email
Dr. Jay Pasricha	Mayo Clinic	4803014679		Pasricha.Jay@mayo.edu

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jan 16, 2024	Mar 30, 2026	Prot_SAP_000.pdf

ID	Term
D018589	Gastroparesis

ID	Term
D013272	Stomach Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010243	Paralysis

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.