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Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis

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ClinicalTrials.gov Identifier: NCT00595621
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : May 5, 2015
Sponsor:
Collaborators:
GI Stimulation, Inc.
National Institutes of Health (NIH)
American Diabetes Association
Information provided by (Responsible Party):
University of Kansas Medical Center ( University of Kansas )

Brief 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.

Condition or disease Intervention/treatment Phase
Gastric Stasis Device: Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis
Study Start Date : February 2006
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Percentage of slow wave entrainment, percentage of gastric retention of a solid meal, gastroparesis-GI symptom severity score improvement [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. Quality of Life, HbA1c level, number of hospital admissions, adverse events [ Time Frame: 12 Weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00595621


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
GI Stimulation, Inc.
National Institutes of Health (NIH)
American Diabetes Association
Investigators
Principal Investigator: Richard W. McCallum, MD University of Kansas Medical Center

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT00595621     History of Changes
Other Study ID Numbers: 9459
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015

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