Gastric Pacemaker Implantation for Gastroparesis

Not Applicable

Withdrawn

• Conditions: Gastroparesis
• Interventions: Device: Enterra Gastric Pacemaker

• Registration Number: NCT00568373
• Lead Sponsor: Indiana University

Brief Summary

Gastric pacemakers and/or temporary gastric stimulators will be implanted in eligible patients.

Detailed Description

Due to HUD status, this protocol is for implant only. This is NOT a clinical trial.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2007-12-05
• Study First Posted: 2007-12-06
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-03
• Last Update Posted: 2021-03-05
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatement	Enterra Gastric Pacemaker	All subjects that meet the requirement for gastric stimulator placement