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GastroparesisNCT02022826

Clinical Management With SPM System and Validation of the SPM 5 Hour Cutoff in Patients With Symptoms of Gastroparesis

A study testing SmartPill Monitoring System in people with Gastroparesis, run by Medtronic - MITG at 11 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Gastroparesis
What is being tested?
SmartPill Monitoring System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
167 participants
Where
11 sitesUnited States
Study dates
Jan 2014to Mar 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Georgia Regents University

    Augusta, Georgia, 30909

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Fletcher Allen Health Care

    Burlington, Vermont, 05401

  • Clinsearch,LLC

    Chattanooga, Tennessee, 37421

  • Texas Tech University

    El Paso, Texas, 79905

  • Indiana University

    Indianapolis, Indiana, 46202

  • Florida Digestive Health

    Largo, Florida, 33777

  • Miami miller school of Medicin

    Miami, Florida

  • Stanford University

    Palo Alto, California, 94305

  • Temple University

    Philadelphia, Pennsylvania, 19140

Other trials in United States

About this study

Official title: Clinical Management With SmartPill Motility Monitoring System and Validation of the SmartPill Five Hour Cutoff in Patients With Symptoms of Gastroparesis

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.

Conditions
Gastroparesis
Being tested
SmartPill Monitoring System
Keywords
Gastroparesis, SmartPill Monitoring System (SPM), Gastric Emptying Scintigraphy (GES)
Medical subject headings
Gastroparesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SmartPill Monitoring SystemDevice

    Also called SPM

Study groups in NCT02022826
Study groupRoleWhat they receive
SmartPill Monitoring SystemExperimentalpatients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
Receives: Device: SmartPill Monitoring System

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: an expected average of two weeks from study procedure

Secondary outcomes (1)

  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

    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)

    Measured: an expected average of two weeks from study procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionMar 2017
  4. Study completionMar 2017

Why it stopped: sponsor internal decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02022826
Sponsor's protocol ID
MA-501
Status last verified
Aug 2017
First submitted
15 Dec 2013
Last updated
30 Nov 2017
Data monitoring committee
No

Publications

  • Ziyang JK, Kuo B, Surjanhata B. Tailored Prokinetic Therapy in Gastroparesis Using Gastric Emptying and Contractility. Neurogastroenterol Motil. 2026 Oct;38(10):e70463. doi: 10.1111/nmo.70463.

    PubMed 42864731

  • 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.

    PubMed 40033166

  • 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.

    PubMed 37913936

  • 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.

    PubMed 32971231

  • 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.

    PubMed 31663906

  • 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.

    PubMed 30557741

Questions about this trial

What is this clinical trial studying?

A study testing SmartPill Monitoring System in people with Gastroparesis, run by Medtronic - MITG at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Per Patient Device Agreement Between SmartPill Motility Monitoring System Gastric Emptying Time & Gastric Emptying Scintigraphy Test in Patients With Symptoms of Gastroparesis (time frame: an expected average of two weeks from study procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02022826, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.

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