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

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ClinicalTrials.gov Identifier: NCT02022826
Recruitment Status : Terminated (sponsor internal decision)
First Posted : December 30, 2013
Results First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Tracking Information
First Submitted Date  ICMJE December 15, 2013
First Posted Date  ICMJE December 30, 2013
Results First Submitted Date  ICMJE August 20, 2017
Results First Posted Date  ICMJE November 30, 2017
Last Update Posted Date November 30, 2017
Study Start Date  ICMJE January 2014
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2013)
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 ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2017)
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 [ Time Frame: 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2013)
Agreement between Gastric emptying time of SmartPill capsule and gastroduodenal contractility and percent of radiolabeled meal retained at 4 hours on scintigraphy [ Time Frame: an expected average of two weeks from study procedure ]
Agreement between Gastric emptying time of SmartPill capsule (GET>8hrs= severe) and gastroduodenal contractility (36) and percent of radiolabeled meal retained at 4 hours on scintigraphy (>35% = severe)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Management With SPM System and Validation of the SPM 5 Hour Cutoff in Patients With Symptoms of Gastroparesis
Official Title  ICMJE Clinical Management With SmartPill Motility Monitoring System and Validation of the SmartPill Five Hour Cutoff in Patients With Symptoms of Gastroparesis
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Gastroparesis
Intervention  ICMJE Device: SmartPill Monitoring System
Other Name: SPM
Study Arms  ICMJE Experimental: SmartPill Monitoring System
patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
Intervention: Device: SmartPill Monitoring System
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 4, 2016)
167
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2013)
250
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02022826
Other Study ID Numbers  ICMJE MA-501
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic - MITG
Study Sponsor  ICMJE Medtronic - MITG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Braden Kuo, Dr.
PRS Account Medtronic - MITG
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP