Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis

• Sponsor: University of Kansas Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00595621
• Collaborator: GI Stimulation, Inc. (Industry), National Institutes of Health (NIH) (NIH), American Diabetes Association (Other)
• Enrollment: 22
• Location: 1
• Arms: 2
• Duration (Months): 40
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Stasis	Device: Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)	N/A

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.

Study Design

• Study Type: Interventional
• 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: Feb 1, 2006
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: MGP-1 ON Experimental Pacemaker on for 6 weeks	Device: Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1); Multi-Channel Phased Gastric Pacemaker (MGP-1)
Active Comparator: MGP-1 OFF Experimental Pacemaker on or off for 4 weeks	Device: Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1); Multi-Channel Phased Gastric Pacemaker (MGP-1)

Outcome Measures

Primary Outcome Measures

1. Percentage of Slow Wave Entrainment [12 Weeks]

   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

1. The Percent (Percentage) of Gastric Retention of a Solid Meal [12 Weeks]

   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.

2. Severity of Gastroparetic Symptoms [12 weeks]

   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.

3. Changes in Quality of Life (QoL) Assessment (Physical (P) and Mental (M)) [12 Weeks]

   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.

4. Changes in Hemoglobin A1c (HbA1c) Level [12 Weeks]

   HbA1c was evaluated at the baseline and after completion of all the phases of the study

5. Changes in Hospital Admissions [12 Weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Richard W. McCallum, MD, University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT00595621
• Other Study ID Numbers: 9459
• First Posted: Jan 16, 2008
• Last Update Posted: May 31, 2019
• Last Verified: May 1, 2019

• Additional relevant MeSH terms: Gastroparesis

Study Results

Participant Flow

Recruitment Details	Diabetic gastroparetic patients who qualified to participate in this study based on inclusionary criteria were recruited from the Gastroenterology Motility Clinic of KUMC in Kansas City, KS
Pre-assignment Detail	All subjects underwent an open-label phase where multi-channel gastric pacemaker (MGP-1) was turned "ON" for 6 weeks. After this phase they were randomized in double blind fashion to MGP-1 "ON" or "OFF" for another 4 weeks. 3 participants were not randomized to continue the study after the open-label phase.

Arm/Group Title	MGP-1 "ON"	MGP-1 "OFF"
Arm/Group Description	Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase. Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)	Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase. Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
Period Title: Open Label Run in
STARTED	22	0
COMPLETED	19	0
NOT COMPLETED	3	0
Period Title: Open Label Run in
STARTED	10	9
COMPLETED	8	8
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	MGP-1 "ON"	MGP-1 "OFF"	Total
Arm/Group Description	Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase. Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)	Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase. Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)	Total of all reporting groups
Overall Participants	10	9	19
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	9 100%	19 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	42	40	42
Sex: Female, Male (Count of Participants)
Female	7 70%	5 55.6%	12 63.2%
Male	3 30%	4 44.4%	7 36.8%
Region of Enrollment (participants) [Number]
United States	10 100%	9 100%	19 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MGP-1 "ON"	MGP-1 "OFF"
Arm/Group Description	Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase. Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)	Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase. Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
Measure Participants	8	8
Baseline Pre-Randomization Phase	72 (3)	70 (2)
Post-Randomization Phase	84 (2)	78 (1.5)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MGP-1 "ON"	MGP-1 "OFF"
Arm/Group Description	Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase. Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)	Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase. Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
Measure Participants	8	8
Baseline Pre-Randomization Phase	46	36
Post-Randomization Phase	33	42

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MGP-1 "ON"	MGP-1 "OFF"
Arm/Group Description	Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase. Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)	Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase. Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
Measure Participants	8	8
Baseline Pre-Randomization Phase	13 (1.2)	14 (1)
Post-Randomization Phase	6 (1.1)	16 (1.1)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MGP-1 "ON"	MGP-1 "OFF"
Arm/Group Description	Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase. Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)	Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase. Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
Measure Participants	8	8
Physical Score	60 (21)	30 (11)
Mental Score	55 (19)	40 (14)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MGP-1 "ON"	MGP-1 "OFF"
Arm/Group Description	Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase. Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)	Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase. Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
Measure Participants	8	8
Mean (Full Range) [% HbA1c]	8.1	8.2

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MGP-1 "ON"	MGP-1 "OFF"
Arm/Group Description	Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase. Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)	Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase. Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
Measure Participants	8	8
Mean (Full Range) [days]	1.5	2.1

Adverse Events

Time Frame	Duration of the study, up to 12 weeks.
Arm/Group Title	Open Label Run		MGP-1 "ON"		MPG-1 "OFF"
Arm/Group Description	Experimental Pacemaker on for 6 weeks during the open label phase (preceding MGP-1 "ON" and MPG-1 "OFF" randomization phases). Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)		Experimental Pacemaker on for 6 weeks during the open label phase then on for 4 weeks during the randomization phase. Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)		Experimental Pacemaker on for 6 weeks during the open label phase then off for 4 weeks during the randomization phase. Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1): Multi-Channel Phased Gastric Pacemaker (MGP-1)
All Cause Mortality
	Open Label Run		MGP-1 "ON"		MPG-1 "OFF"
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/10 (0%)		0/9 (0%)
Serious Adverse Events
	Open Label Run		MGP-1 "ON"		MPG-1 "OFF"
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/10 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	Open Label Run		MGP-1 "ON"		MPG-1 "OFF"
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/22 (4.5%)		2/10 (20%)		0/9 (0%)
Gastrointestinal disorders
Dislodgement of the electrode(s)	0/22 (0%)	0	2/10 (20%)	2	0/9 (0%)	0
Product Issues
Technical issue with the MGP-1 system	1/22 (4.5%)	1	0/10 (0%)	0	0/9 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.