Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis

University of Kansas

Status: Completed

Conditions: Gastric Stasis

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

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00595621

9459

Details and patient eligibility

About

Investigate the safety and efficacy of multi-channel gastric electrical stimulation in the treatment of patients with severe diabetic gastroparesis refractory to standard therapy.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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22 participants in 2 patient groups

MGP-1 ON

Active Comparator group

Description:

Experimental Pacemaker on for 6 weeks

Treatment:

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

MGP-1 OFF

Active Comparator group

Description:

Experimental Pacemaker on or off for 4 weeks

Treatment:

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