Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis

NCT ID: NCT00595621

Last Updated: 2019-05-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2009-06-30

Brief Summary

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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

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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.

Conditions

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Gastric Stasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MGP-1 ON

Experimental Pacemaker on for 6 weeks

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Multi-Channel Phased Gastric Pacemaker (MGP-1)

MGP-1 OFF

Experimental Pacemaker on or off for 4 weeks

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Multi-Channel Phased Gastric Pacemaker (MGP-1)

Interventions

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

Multi-Channel Phased Gastric Pacemaker (MGP-1)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GI Stimulation, Inc.

INDUSTRY

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

American Diabetes Association

OTHER

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard W. McCallum, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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9459

Identifier Type: -

Identifier Source: org_study_id

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