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Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis

Primary Purpose

Gastric Stasis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Stasis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MGP-1 ON

MGP-1 OFF

Arm Description

Experimental Pacemaker on for 6 weeks

Experimental Pacemaker on or off for 4 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
Changes in Hemoglobin A1c (HbA1c) Level
HbA1c was evaluated at the baseline and after completion of all the phases of the study
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.

Full Information

First Posted
January 7, 2008
Last Updated
May 30, 2019
Sponsor
University of Kansas Medical Center
Collaborators
GI Stimulation, Inc., National Institutes of Health (NIH), American Diabetes Association
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1. Study Identification

Unique Protocol Identification Number
NCT00595621
Brief Title
Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis
Official Title
Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
GI Stimulation, Inc., National Institutes of Health (NIH), American Diabetes Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 diabetic gastroparesis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Stasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MGP-1 ON
Arm Type
Active Comparator
Arm Description
Experimental Pacemaker on for 6 weeks
Arm Title
MGP-1 OFF
Arm Type
Active Comparator
Arm Description
Experimental Pacemaker on or off for 4 weeks
Intervention Type
Device
Intervention Name(s)
Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)
Intervention Description
Multi-Channel Phased Gastric Pacemaker (MGP-1)
Primary Outcome Measure Information:
Title
Percentage of Slow Wave Entrainment
Description
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
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
The Percent (Percentage) of Gastric Retention of a Solid Meal
Description
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.
Time Frame
12 Weeks
Title
Severity of Gastroparetic Symptoms
Description
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.
Time Frame
12 weeks
Title
Changes in Quality of Life (QoL) Assessment (Physical (P) and Mental (M))
Description
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.
Time Frame
12 Weeks
Title
Changes in Hemoglobin A1c (HbA1c) Level
Description
HbA1c was evaluated at the baseline and after completion of all the phases of the study
Time Frame
12 Weeks
Title
Changes in Hospital Admissions
Description
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.
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard W. McCallum, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis

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