Enterra Therapy Gastric Stimulation System
| Status: | Terminated |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/21/2016 |
| Start Date: | October 2004 |
| End Date: | September 2008 |
Enterra Therapy Gastric Simulation System (Enterra Therapy) is indicated for the treatment
of patients with long term, uncontrolled (not helped by medication) nausea and vomiting from
gastroparesis of diabetic or idiopathic origin.
In March 2000, the Food and Drug Administration (FDA) gave approval of a humanitarian Device
Exemption (HDE) of a Humanitarian Use Device (HUD) for Enterra Therapy Gastric electrical
(GES) Simulation System. Although, there is evidence that suggests the use of Enterra
Therapy System probably helps patients, symptoms, the FDA's HDE approval indicates that the
helpfulness of this therapy has not been proven. Physicians at Columbia University Medical
Center hope to prove the helpfulness of this device.
of patients with long term, uncontrolled (not helped by medication) nausea and vomiting from
gastroparesis of diabetic or idiopathic origin.
In March 2000, the Food and Drug Administration (FDA) gave approval of a humanitarian Device
Exemption (HDE) of a Humanitarian Use Device (HUD) for Enterra Therapy Gastric electrical
(GES) Simulation System. Although, there is evidence that suggests the use of Enterra
Therapy System probably helps patients, symptoms, the FDA's HDE approval indicates that the
helpfulness of this therapy has not been proven. Physicians at Columbia University Medical
Center hope to prove the helpfulness of this device.
Gastroparesis is a debilitating disease in which patients suffer from a number of upper
gastrointestinal (GI) symptoms including nausea, vomiting, early satiety, bloating,
postprandial fullness, epigastric pain and burning, and cardiac pain and burning. Severe
symptoms, particularly vomiting and nausea, can significantly impair a patients daily
activities and quality of life.
Current medical practice for the treatment and/or management of gastroparesis consists of
dietary modifications, drug therapies, enteral feeding, parenteral feeding and surgery.
These treatments are successful for some patients, but have significant drawbacks. Patients
may initially be treated with various dietary modifications including frequent low fat
meals. However, if dietary modifications alone are unsuccessful, antiemetic and prokinetic
drugs, or combinations thereof, are generally tried. If symptoms cannot be controlled with
medication, supplemental nutrition via enteral or parenteral feeding may be required to
maintain hydration and nutritional status. Prokinetic drugs are intended to promote gastric
motility, i.e., to return abnormally slow gastric emptying states to normal. Antiemetic
drugs are intended to alleviate symptoms of nausea and vomiting, but have no effect on
motility. None of the prokinetic drugs are labeled for improved gastric emptying in
gastroparesis. Metoclopramide is the only antiemetic or prokinetic drug indicated for use in
the treatment of symptoms of diabetic gastroparesis.
Surgical procedures are occasionally employed to manage symptoms of gastroparesis while
maintaining the ability for enteral feeding. Surgical procedures, including gastrectomy,
pyloroplasty, and gastrojejunostomy, have had limited success in managing symptoms of
gastroparesis. When drug therapies or surgery are ineffective, supplemental enteral feeding
via gastric or jejunal feeding tubes or total parenteral nutrition (TPN) may be required to
meet the patient's nutritional needs.
For those patients who cannot be adequately treated or managed by current medical practice,
the GES has no satisfactory alternative. It is this group of patients for which the GES
System is indicated.
gastrointestinal (GI) symptoms including nausea, vomiting, early satiety, bloating,
postprandial fullness, epigastric pain and burning, and cardiac pain and burning. Severe
symptoms, particularly vomiting and nausea, can significantly impair a patients daily
activities and quality of life.
Current medical practice for the treatment and/or management of gastroparesis consists of
dietary modifications, drug therapies, enteral feeding, parenteral feeding and surgery.
These treatments are successful for some patients, but have significant drawbacks. Patients
may initially be treated with various dietary modifications including frequent low fat
meals. However, if dietary modifications alone are unsuccessful, antiemetic and prokinetic
drugs, or combinations thereof, are generally tried. If symptoms cannot be controlled with
medication, supplemental nutrition via enteral or parenteral feeding may be required to
maintain hydration and nutritional status. Prokinetic drugs are intended to promote gastric
motility, i.e., to return abnormally slow gastric emptying states to normal. Antiemetic
drugs are intended to alleviate symptoms of nausea and vomiting, but have no effect on
motility. None of the prokinetic drugs are labeled for improved gastric emptying in
gastroparesis. Metoclopramide is the only antiemetic or prokinetic drug indicated for use in
the treatment of symptoms of diabetic gastroparesis.
Surgical procedures are occasionally employed to manage symptoms of gastroparesis while
maintaining the ability for enteral feeding. Surgical procedures, including gastrectomy,
pyloroplasty, and gastrojejunostomy, have had limited success in managing symptoms of
gastroparesis. When drug therapies or surgery are ineffective, supplemental enteral feeding
via gastric or jejunal feeding tubes or total parenteral nutrition (TPN) may be required to
meet the patient's nutritional needs.
For those patients who cannot be adequately treated or managed by current medical practice,
the GES has no satisfactory alternative. It is this group of patients for which the GES
System is indicated.
Inclusion Criteria:
- Chronic(long term, lasting greater than 3 months)
- Intractable (drug refractory, failed medical management with prokinetic and
antiemetic drugs
- Failed dietary modifications, and/or requiring enteral feeding) nausea and vomiting
secondary to gastroparesis of diabetic or idiopathic etiology
Exclusion Criteria:
- Only patients whom the physician determines are not a candidate for surgical
procedures and/or anesthesia due to physical or mental conditions will be excluded.
This includes pregnant women, anyone unable to tolerate general anesthesia, and
uncorrectable coagulopathy.
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