Gastric Pacemaker Implantation for Gastroparesis

Gastric Electric Stimulation-Enterra Therapy for the Treatment of Chronic Intractable (Drug Refractory) Nausea and Vomiting Secondary to Gastroparesis of Diabetic or Idiopathic Etiology

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00568373

Acronym

HUD

Enrollment

Registered

2007-12-06

Start date

2007-06-30

Completion date

2025-12-31

Last updated

2021-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroparesis

Keywords

Gastroparesis, Gastric electrical stimulator

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.

Interventions

DEVICEEnterra Gastric Pacemaker

Gastric Pacemaker

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

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

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026