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Completed

NCT Number: NCT00595621

Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis

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

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Key information

Conditions

Gastric Stasis Digestive System Diseases Gastrointestinal Diseases Gastroparesis Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Multi-Channel Phased Gastric Pacemaker (MGP-1)

Primary outcomes

  1. Percentage of Slow Wave Entrainment

    Time frame: 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 outcomes

  1. The Percent (Percentage) of Gastric Retention of a Solid Meal

    Time frame: 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

    Time frame: 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))

    Time frame: 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

    Time frame: 12 Weeks

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

  5. Changes in Hospital Admissions

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

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

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 16, 2008
Registry last updated
May 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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