Clinical Management With SPM System and Validation of the SPM 5 Hour Cutoff in Patients With Symptoms of Gastroparesis
NCT ID: NCT02022826
Last Updated: 2017-11-30
Study Results
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View full resultsBasic Information
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TERMINATED
NA
167 participants
INTERVENTIONAL
2014-01-31
2017-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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SmartPill Monitoring System
patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
SmartPill Monitoring System
Interventions
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SmartPill Monitoring System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Medtronic - MITG
INDUSTRY
Responsible Party
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Principal Investigators
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Braden Kuo, Dr.
Role: PRINCIPAL_INVESTIGATOR
Locations
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Stanford University
Palo Alto, California, United States
Florida Digestive Health
Largo, Florida, United States
Miami miller school of Medicin
Miami, Florida, United States
Georgia Regents University
Augusta, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Temple University
Philadelphia, Pennsylvania, United States
Clinsearch,LLC
Chattanooga, Tennessee, United States
Texas Tech University
El Paso, Texas, United States
Fletcher Allen Health Care
Burlington, Vermont, United States
Countries
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References
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Surjanhata BC, Moshiree B, Lee AA, McCallum RW, Sarosiek I, Nguyen LA, Schulman MI, Wo JM, Parkman HP, Kuo B, Hasler WL, Rao SSC. Impact of Constipation Therapies on Severity of Gastroparesis and Constipation Symptoms in Relation to Gastric and Colonic Transit. Neurogastroenterol Motil. 2025 Jun;37(6):e70013. doi: 10.1111/nmo.70013. Epub 2025 Mar 3.
Hasler WL, Lee AA, Moshiree B, Surjanhata BC, Rao S, Parkman HP, Nguyen LA, Sarosiek I, Wo JM, Schulman MI, McCallum RW, Kuo B. Benefits of Prokinetics, Gastroparesis Diet, or Neuromodulators Alone or in Combination for Symptoms of Gastroparesis. Clin Gastroenterol Hepatol. 2024 Apr;22(4):867-877.e12. doi: 10.1016/j.cgh.2023.10.014. Epub 2023 Oct 30.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MA-501
Identifier Type: -
Identifier Source: org_study_id