Gastroparesis
Conditions
Keywords
Gastroparesis, SmartPill Monitoring System (SPM), Gastric Emptying Scintigraphy (GES)
Brief summary
This protocol is designed to validate use of the SPM for diagnosis of delayed gastric emptying in patients with symptoms of gastroparesis and assess impact of a SmartPill study on patient management in the gastroparetic populations. Patients with symptoms of gastroparesis will be recruited. Patients will undergo concurrent gastric scintigraphy and SPM testing to determine the presence or absence of delayed gastric emptying based on predetermined diagnostic cutoffs for each technique.
Interventions
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Males and females between ages of 18-80 years of age with symptoms of gastroparesis for at least 12 weeks. * Presenting with 2 or more of the following symptoms or signs which, in the opinion of the site investigator, are suggestive of a diagnosis of gastroparesis: * 1 Nausea, vomiting, or retching (dry heaves) * 2 Postprandial fullness or early satiety * 3 Bloating or visible abdominal distention * 4 Postprandial discomfort or pain * Ability to stop proton pump inhibitors for 7 days and histamine2 receptor antagonists, prokinetic agents, narcotic agents, anticholinergic drugs, and cannabinoids 3 days prior to SPM and gastric scintigraphy testing. * No evidence of metabolic disease (hypothyroidism, uncontrolled diabetes \[hemoglobin A1c \>10% within the past 6 months\], electrolyte imbalance). * An upper endoscopy or upper gastrointestinal barium series within the past 2 years showing no organic disease that is potentially causative of symptoms. * High probability of compliance and completion of study.
Exclusion criteria
* Participation in previous SmartPill clinical trials. * Previous history of bezoars (the presence of retained liquid, bile, or small amounts of poorly organized food residue is permitted). * Dysphagia to solid food or pills. * Prior surgery involving the luminal gastrointestinal tract (cholecystectomy, appendectomy, and hysterectomy are permitted if performed \> 3 months prior to SPM test). * Any abdominal or pelvic surgery within the past 3 months * Known or history of inflammatory bowel disease. * History of diverticulitis, diverticular stricture, and other intestinal strictures. * Chronic daily use of nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen, etc.) * Tobacco or alcohol use within eight hours prior to capsule ingestion. * BMI \> 40 kg/m2. * Allergies to eggs, bread, or jam. * Females of childbearing age who are not practicing birth control and/or are pregnant or lactating. (Urine pregnancy testing will be performed on female subjects of child-bearing potential prior to capsule ingestion and gastric scintigraphy). * Use of cardiac medical devices such as pacemakers and defibrillators (gastric stimulators, bladder stimulators, spinal stimulators, medication infusion devices, insulin pumps, continuous glucose monitors are permitted). * Uncontrolled diabetes with a hemoglobin A1c \>10%. * Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Per Patient Device Agreement Between SmartPill Motility Monitoring System Gastric Emptying Time & Gastric Emptying Scintigraphy Test in Patients With Symptoms of Gastroparesis | an expected average of two weeks from study procedure | Per patient device agreement for the diagnosis of delayed gastric emptying between SmartPill Motility Monitoring System (SPM) gastric emptying time (GET \>5 hours) and the non-reference standard, gastric Emptying scintigraphy test (\>10% retention of a solid meal at 4 hours) in patients with symptoms of gastroparesis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agreement Between Gastric Emptying Time of SmartPill Capsule and Gastroduodenal Contractility and Percent of Radiolabeled Meal Retained at 4 Hours on Scintigraphy for Severe Gastroparesis | an expected average of two weeks from study procedure | Agreement between Gastric emptying time of SmartPill capsule (GET\>8hrs= severe) and gastroduodenal contractility and percent of radiolabeled meal retained at 4 hours on scintigraphy (\>35% = severe) |
Countries
United States
Participant flow
Recruitment details
Recruitment period- January 2014 March 2017; 11 academic and community centers within the US
Pre-assignment details
medication wash out period: Subjects instructed to discontinue agents that affect intragastric acidity including proton pump inhibitors for 7 days, histamine2 receptor antagonists for 3 days and antacids for 1 day prior to study including the day of SPM ingestion.
Participants by arm
| Arm | Count |
|---|---|
| SmartPill Monitoring System patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test | 167 |
| Total | 167 |
Baseline characteristics
| Characteristic | SmartPill Monitoring System | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 13 Participants | — |
| Age, Categorical Between 18 and 65 years | 154 Participants | — |
| Age, Continuous | 45 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 167 participants | — |
| Sex: Female, Male Female | 131 Participants | — |
| Sex: Female, Male Male | 36 Participants | — |
| suspected gastroparesis | 167 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 167 |
| other Total, other adverse events | 18 / 167 |
| serious Total, serious adverse events | 10 / 167 |
Outcome results
Primary
Per Patient Device Agreement Between SmartPill Motility Monitoring System Gastric Emptying Time & Gastric Emptying Scintigraphy Test in Patients With Symptoms of Gastroparesis
Per patient device agreement for the diagnosis of delayed gastric emptying between SmartPill Motility Monitoring System (SPM) gastric emptying time (GET \>5 hours) and the non-reference standard, gastric Emptying scintigraphy test (\>10% retention of a solid meal at 4 hours) in patients with symptoms of gastroparesis
Time frame: an expected average of two weeks from study procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SmartPill Monitoring System | Per Patient Device Agreement Between SmartPill Motility Monitoring System Gastric Emptying Time & Gastric Emptying Scintigraphy Test in Patients With Symptoms of Gastroparesis | 76 percentage of agreement |
p-value: 0.005295% CI: [69, 83]McNemar
Secondary
Agreement Between Gastric Emptying Time of SmartPill Capsule and Gastroduodenal Contractility and Percent of Radiolabeled Meal Retained at 4 Hours on Scintigraphy for Severe Gastroparesis
Agreement between Gastric emptying time of SmartPill capsule (GET\>8hrs= severe) and gastroduodenal contractility and percent of radiolabeled meal retained at 4 hours on scintigraphy (\>35% = severe)
Time frame: an expected average of two weeks from study procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SmartPill Monitoring System | Agreement Between Gastric Emptying Time of SmartPill Capsule and Gastroduodenal Contractility and Percent of Radiolabeled Meal Retained at 4 Hours on Scintigraphy for Severe Gastroparesis | 92 percentage of agreement |
p-value: 195% CI: [87, 96]McNemar