Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis

Gastric Stasis Clinical Trial

Official title:

Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00595621
• Other study ID #: 9459
• Status: Completed
• Phase: N/A
• Start date: February 2006
• Est. completion date: June 2009

Study information

• Verified date: May 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 diabetic gastroparesis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Stasis
• Gastroparesis

Intervention

Device:
• Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)
Multi-Channel Phased Gastric Pacemaker (MGP-1)

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (4)

Lead Sponsor	Collaborator
University of Kansas Medical Center	American Diabetes Association, GI Stimulation, Inc., National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Percent (Percentage) of Gastric Retention of a Solid Meal	The retention of a study meal was measured at baseline, 1,2,3 and 4 hours of the test. The percent of food retained in a stomach at 4 hours was compared when MGP-1 was ON and OFF.	12 Weeks
Secondary	Severity of Gastroparetic Symptoms	Measure represents change in symptom severity as measured by a self assessment Symptom Interview Form evaluating severity of vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain, and epigastric burning. Symptoms were rated from 0 - absence of symptom to 4 - extremely severe. The overall score was calculated from the sum of seven symptom sub-scores with a total possible score range of 0 - absence of all symptoms to 28 - all symptoms extremely severe.	12 weeks
Secondary	Changes in Quality of Life (QoL) Assessment (Physical (P) and Mental (M))	Measure represents percentage change from baseline to end of study. QoL measured using the Short Form Health Survey (SF-36) questionnaire. The SF-36 is a generic measure of QoL. Physical QoL (Physical Component Summary; PCS) and emotional QoL (Mental Component summary; MCS) scale components of the survey used for outcome. Scores range from 0 to 100 with lower scores indicating more disability and higher scores less disability.	12 Weeks
Secondary	Changes in Hemoglobin A1c (HbA1c) Level	HbA1c was evaluated at the baseline and after completion of all the phases of the study	12 Weeks
Secondary	Changes in Hospital Admissions	Measured by days of hospitalization per patient. Number of days of hospitalization was recorded at baseline and after completion of all phases of the study.	12 Weeks