Clinical trial NCT02022826: Clinical Management With SPM System and Validation of the SPM 5 Hour Cutoff in Patients With Symptoms of Gastroparesis
Official title: Clinical Management With SmartPill Motility Monitoring System and Validation of the SmartPill Five Hour Cutoff in Patients With Symptoms of Gastroparesis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastroparesis
Keywords: Gastroparesis
SmartPill Monitoring System (SPM)
Gastric Emptying Scintigraphy (GES)
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2013-12-30
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Per Patient Device Agreement Between SmartPill Motility Monitoring System Gastric Emptying Time & Gastric Emptying Scintigraphy Test in Patients With Symptoms of Gastroparesis
timeFrame: an expected average of two weeks from study procedure
Secondary outcomes:
measure: 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
timeFrame: an expected average of two weeks from study procedure
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Largo
country: United States
facility: Florida Digestive Health
state: Florida
city: Miami
country: United States
facility: Miami miller school of Medicin
state: Florida
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Chattanooga
country: United States
facility: Clinsearch,LLC
state: Tennessee
city: El Paso
country: United States
facility: Texas Tech University
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
Study officials:
name: Braden Kuo, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee AA, Rao K, Parkman HP, McCallum RW, Sarosiek I, Nguyen LA, Wo JM, Schulman MI, Moshiree B, Rao S, Kuo B, Hasler WL. Baseline Predictors of Longitudinal Changes in Symptom Severity and Quality of Life in Patients With Suspected Gastroparesis. Clin Gastroenterol Hepatol. 2022 Mar;20(3):e407-e428. doi: 10.1016/j.cgh.2020.09.032. Epub 2020 Sep 21.
citation: Hasler WL, Rao SSC, McCallum RW, Krause RA, Nguyen LA, Schulman MI, Lee AA, Moshiree B, Wo JM, Parkman HP, Sarosiek I, Wilding GE, Kuo B. Influence of Gastric Emptying and Gut Transit Testing on Clinical Management Decisions in Suspected Gastroparesis. Clin Transl Gastroenterol. 2019 Oct;10(10):e00084. doi: 10.14309/ctg.0000000000000084.
citation: Lee AA, Rao S, Nguyen LA, Moshiree B, Sarosiek I, Schulman MI, Wo JM, Parkman HP, Wilding GE, McCallum RW, Hasler WL, Kuo B. Validation of Diagnostic and Performance Characteristics of the Wireless Motility Capsule in Patients With Suspected Gastroparesis. Clin Gastroenterol Hepatol. 2019 Aug;17(9):1770-1779.e2. doi: 10.1016/j.cgh.2018.11.063. Epub 2018 Dec 14.