Gastric Pacemaker Implantation for Gastroparesis (HUD)

Indiana University

Status: Withdrawn

Conditions: Gastroparesis

Treatments: Device: Enterra Gastric Pacemaker

Study type: Interventional

Funder types: Other

Identifiers

NCT00568373

0705-32

Details and patient eligibility

About

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

Full description

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

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Treatement

Experimental group

Description:

All subjects that meet the requirement for gastric stimulator placement

Treatment:

Device: Enterra Gastric Pacemaker