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

NCT02022826 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2017-11-30

Study results available
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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.

Conditions

Interventions

DEVICE

SmartPill Monitoring System

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Braden Kuo, Dr.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02022826 on ClinicalTrials.gov