Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 7, 2008
CompletedFirst Posted
Study publicly available on registry
January 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
May 31, 2019
CompletedMay 31, 2019
May 1, 2019
3.3 years
January 7, 2008
April 7, 2017
May 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Slow Wave Entrainment
Participants were monitored for up to 3 months. Measure is the percent of normal slow waves (2-4 cpm) generated by MGP-1 device while it was ON or OFF
12 Weeks
Secondary Outcomes (5)
The Percent (Percentage) of Gastric Retention of a Solid Meal
12 Weeks
Severity of Gastroparetic Symptoms
12 weeks
Changes in Quality of Life (QoL) Assessment (Physical (P) and Mental (M))
12 Weeks
Changes in Hemoglobin A1c (HbA1c) Level
12 Weeks
Changes in Hospital Admissions
12 Weeks
Study Arms (2)
MGP-1 ON
ACTIVE COMPARATORExperimental Pacemaker on for 6 weeks
MGP-1 OFF
ACTIVE COMPARATORExperimental Pacemaker on or off for 4 weeks
Interventions
Multi-Channel Phased Gastric Pacemaker (MGP-1)
Eligibility Criteria
You may qualify if:
- Severe nausea and vomiting for at least 6 months
- Documented delayed gastric emptying
- Failed extensive medical treatment
You may not qualify if:
- Previous gastric surgery
- Pregnancy or planned pregnancy
- Primary eating or swallowing disorders
- Scheduled or planned MRI testing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Kansas Medical Centerlead
- GI Stimulation, Inc.collaborator
- National Institutes of Health (NIH)collaborator
- American Diabetes Associationcollaborator
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Irene Sarosiek, MD, AGAF, FACG, CCRP
- Organization
- Texas Tech
Study Officials
- PRINCIPAL INVESTIGATOR
Richard W. McCallum, MD
University of Kansas Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2008
First Posted
January 16, 2008
Study Start
February 1, 2006
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
May 31, 2019
Results First Posted
May 31, 2019
Record last verified: 2019-05