Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis

This study has been withdrawn prior to enrollment.
(PI left institution)
Sponsor:
Collaborators:
GI Stimulation, Inc.
American Diabetes Association
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT00595621
First received: January 7, 2008
Last updated: February 16, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention
Gastric Stasis
Device: Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Percentage of slow wave entrainment, percentage of gastric retention of a solid meal, gastroparesis-GI symptom severity score improvement [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of Life, HbA1c level, number of hospital admissions, adverse events [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: February 2006
Estimated Study Completion Date: August 2008
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Experimental Pacemaker on for 6 weeks
Device: Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)
Multi-Channel Phased Gastric Pacemaker (MGP-1)
Active Comparator: 2
Experimental Pacemaker on or off for 4 weeks
Device: Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)
Multi-Channel Phased Gastric Pacemaker (MGP-1)

Detailed Description:

Evaluation of severe symptom control of nausea, vomiting, postprandial fullness, early satiety, bloating and discomfort related to drug refractory gastroparesis present as a GI complication in diabetic patients. External gastric pacemaker system will be placed at the same time of implantation of Enterra (internal gastric stimulator-permanent device) to assess symptoms, quality of life improvement and investigate the changes in gastric emptying time in DM gastroparetics.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe nausea and vomiting for at least 6 months
  • Documented delayed gastric emptying
  • Failed extensive medical treatment

Exclusion Criteria:

  • Previous gastric surgery
  • Pregnancy or planned pregnancy
  • Primary eating or swallowing disorders
  • Scheduled or planned MRI testing
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00595621

Sponsors and Collaborators
University of Kansas
GI Stimulation, Inc.
American Diabetes Association
Investigators
Principal Investigator: Richard W. McCallum, MD University of Kansas
  More Information

No publications provided

Responsible Party: Richard W. McCallum, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00595621     History of Changes
Other Study ID Numbers: 9459
Study First Received: January 7, 2008
Last Updated: February 16, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014