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Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis

NCT00595621 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-05-31

Study results available
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Summary

Investigate the safety and efficacy of multi-channel gastric electrical stimulation in the treatment of patients with severe diabetic gastroparesis refractory to standard therapy.

Conditions

  • Gastric Stasis

Interventions

DEVICE

Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)

Multi-Channel Phased Gastric Pacemaker (MGP-1)

Sponsors & Collaborators

  • GI Stimulation, Inc.

    collaborator INDUSTRY

  • National Institutes of Health (NIH)

    collaborator NIH

  • American Diabetes Association

    collaborator OTHER

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Richard W. McCallum, MD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00595621 on ClinicalTrials.gov