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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 4, 2007 | ||||
| Last Updated Date | June 15, 2009 | ||||
| Start Date ICMJE | June 2007 | ||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Decreased nausea and vomiting. [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Decreased nausea and vomitting. [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00568373 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Gastric Pacemaker Implantation for Gastroparesis | ||||
| Official Title ICMJE | Gastric Electric Stimulation-Enterra Therapy for the Treatment of Chronic Intractable (Drug Refractory) Nausea and Vomiting Secondary to Gastroparesis of Diabetic or Idiopathic Etiology | ||||
| Brief Summary | Gastric pacemakers will be surgically implanted in eligible patients. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Control: Uncontrolled Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Gastroparesis | ||||
| Intervention ICMJE | Device: Enterra Gastric Pacemaker
Gastric Pacemaker |
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| Study Arms / Comparison Groups | 1: Experimental
Gastric pacemaker.
Intervention: Device: Enterra Gastric Pacemaker |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | June 2010 | ||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00568373 | ||||
| Responsible Party | Joel Witles MD, Indiana University | ||||
| Study ID Numbers ICMJE | 0705-32 | ||||
| Study Sponsor ICMJE | Indiana University School of Medicine | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Indiana University | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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