Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis - Full Text View

Sponsors and Collaborators:	University of Kansas GI Stimulation, Inc. National Institutes of Health (NIH) American Diabetes Association
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00595621

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)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
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:	March 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Experimental Pacemaker on for 6 weeks	Device: Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1) Multi-Channel Phased Gastric Pacemaker (MGP-1)
2: Active Comparator 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Responsible Party:	University of Kansas Medical Center ( Richard W. McCallum, MD )
Study ID Numbers:	9459
Study First Received:	January 7, 2008
Last Updated:	January 15, 2008
ClinicalTrials.gov Identifier:	NCT00595621
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Paralysis
Signs and Symptoms
Digestive System Diseases
Stomach Diseases

Gastrointestinal Diseases
Neurologic Manifestations
Gastroparesis

ClinicalTrials.gov processed this record on January 16, 2009