Gastric Pacemaker Implantation for Gastroparesis (HUD)
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ClinicalTrials.gov Identifier: NCT00568373 |
Recruitment Status : Unknown
Verified March 2018 by Joel Wittles, Indiana University.
Recruitment status was: Recruiting
First Posted : December 6, 2007
Last Update Posted : March 30, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastroparesis | Device: Enterra Gastric Pacemaker | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | All patients who have severe symptoms and have been identified by the PI and Sub I to qualify for the treatment will be under one single group |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Gastric Electric Stimulation-Enterra Therapy for the Treatment of Chronic Intractable (Drug Refractory) Nausea and Vomiting Secondary to Gastroparesis of Diabetic or Idiopathic Etiology |
Actual Study Start Date : | June 2007 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatement
All subjects that meet the requirement for gastric stimulator placement
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Device: Enterra Gastric Pacemaker
Gastric Pacemaker |
- Decreased nausea and vomiting. [ Time Frame: 3 months ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Used only if patients have tried and failed conventional treatment ( drug therapy and dietary modification)due to intractable nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568373
Contact: Anita Gupta, MBBS,,MPH | 317-948-9227 | anigupta@iu.edu |
United States, Indiana | |
Indiana University | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Anita Gupta 317-948-9227 anigupta@iu.edu | |
Principal Investigator: Joel Wittles, MD | |
Sub-Investigator: John M Wo, MD | |
Sub-Investigator: Thomas V Nowak, MD | |
Riley Hospital for Children | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Anita Gupta 317-948-9227 anigupta@iu.edu |
Principal Investigator: | Joel Wittles, MD | Indiana University | |
Study Chair: | John M Wo, MD | Indiana University |
Responsible Party: | Joel Wittles, MD, Indiana University |
ClinicalTrials.gov Identifier: | NCT00568373 |
Other Study ID Numbers: |
0705-32 |
First Posted: | December 6, 2007 Key Record Dates |
Last Update Posted: | March 30, 2018 |
Last Verified: | March 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Gastroparesis Gastric electrical stimulator |
Gastroparesis Stomach Diseases Gastrointestinal Diseases |
Digestive System Diseases Paralysis Neurologic Manifestations |