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Clinical studies

Dosing gastric electrical stimulation

Gastric Electrical Stimulation (GES) is gaining renewed attention as a treatment for refractory gastroparesis. While the therapy has been well studied and shown in clinical trials to significantly improve nausea and vomiting symptoms associated with gastroparesis, recent insights suggest that how the therapy is delivered—specifically, through refined dosage of stimulation output—may be driving new clinical enthusiasm.

The role of dosage/titration

Advances in dosage methodology (also referred to as titration), including structured stimulation parameter algorithm approaches used by physicians, such as the table below created by Dr. Michael Awad, enable clinicians to systematically adjust stimulation settings to optimize symptom relief. Rather than treating GES as a fixed dose therapy, adjusting the stimulation parameters allows the physician to fine-tune the stimulation output resulting in a patient-specific intervention. This patient-centric approach to dosing may help patients find the Nausea and Vomiting relief they are looking for.


Voltage (V)On time (sec)Off time (sec)Frequency (Hz)
Day of implant2.0-2.50.1514
1 month (POV)3.50.1514
Patient visit 15.00.1514
Step 2 (if necessary)5.00.5514
Step 3 (if necessary)5.01414
Step 4 (if necessary)5.02314
Step 5 (if necessary)5.03214
Step 6 (if necessary)5.04114
Step 7 (if necessary)5.04128

Stimulation Parameter Algorithm used by Dr. Michael Awad to achieve results in “Clinical Outcomes of a Large, Prospective Series of Gastric Electrical Stimulation Patients Using a Multidisciplinary Protocol” study.

IMPORTANT SAFETY INFORMATION

Enterra Therapy for treatment of chronic, resistant to medication nausea and vomiting associated with gastroparesis caused by diabetes or an unknown origin in patients aged 18 to 70 years: patients should always discuss potential risks and benefits of the device with their physician.

HUMANITARIAN DEVICE

Authorized by Federal law for use in the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years. The effectiveness of this device for this use has not been demonstrated. What does this mean?