Study Stopped
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Clinical Management With SPM System and Validation of the SPM 5 Hour Cutoff in Patients With Symptoms of Gastroparesis
Clinical Management With SmartPill Motility Monitoring System and Validation of the SmartPill Five Hour Cutoff in Patients With Symptoms of Gastroparesis
1 other identifier
interventional
167
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2014
Typical duration for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2013
CompletedFirst Posted
Study publicly available on registry
December 30, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedResults Posted
Study results publicly available
November 30, 2017
CompletedNovember 30, 2017
August 1, 2017
3.2 years
December 15, 2013
August 20, 2017
November 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
an expected average of two weeks from study procedure
Secondary Outcomes (1)
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
Study Arms (1)
SmartPill Monitoring System
EXPERIMENTALpatients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- Nausea, vomiting, or retching (dry heaves)
- Postprandial fullness or early satiety
- Bloating or visible abdominal distention
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic - MITGlead
Study Sites (11)
Stanford University
Palo Alto, California, 94305, United States
Florida Digestive Health
Largo, Florida, 33777, United States
Miami miller school of Medicin
Miami, Florida, United States
Georgia Regents University
Augusta, Georgia, 30909, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Clinsearch,LLC
Chattanooga, Tennessee, 37421, United States
Texas Tech University
El Paso, Texas, 79905, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Related Publications (5)
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.
PMID: 40033166DERIVEDHasler 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.
PMID: 37913936DERIVEDLee 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.
PMID: 32971231DERIVEDHasler 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.
PMID: 31663906DERIVEDLee 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.
PMID: 30557741DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michal Kedar-Datel
- Organization
- Medtronic
Study Officials
- PRINCIPAL INVESTIGATOR
Braden Kuo, Dr.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2013
First Posted
December 30, 2013
Study Start
January 1, 2014
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
November 30, 2017
Results First Posted
November 30, 2017
Record last verified: 2017-08