Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis)

Not Applicable

Terminated

Brief Summary: This study is to evaluate the safety and effectiveness of gastric stimulation in the reduction of nausea and vomiting in patients with gastroparesis using an approved Humanitarian device. There are two cohorts in this study based on etiology, one for diabetic and one for idiopathic.

A maximum of 150 patients (75 diabetic and 75 idiopathic) from up to 15 centers in the United States will be followed closely for twelve months and then once a year after that until the study closes.

If you are someone suffering with symptoms of gastroparesis despite trying oral medications, you may be eligible to participate in a clinical study using a surgically implanted gastric stimulator.

Recruitment & Eligibility

Inclusion Criteria

Male or Female at least 18 years of age
Diagnosed with gastroparesis due to diabetes or an unknown cause (idiopathic)
Have tried prokinetic (help the stomach empty quicker) and antiemetic (help decrease symptoms of nausea and vomiting) medications for a minimum of one month, unless you're unable to take these types of medications
Have symptoms of gastroparesis that have required treatment for at least one year
Experience at least 7 episodes of vomiting during a seven consecutive day period on a 28-day diary
Willing and able to completely and accurately fill out a diary and questionnaires throughout the study
Have gastric retention of greater than 10% at four hours, or greater than 60% at two hours (if unable to complete the four-hour test) on a Gastric Emptying Test (GET)

Exclusion Criteria

Primary Outcome Measures

Name	Time	Method
Percent Reduction in Frequency of Weekly Vomiting Episodes When the Device is Turned ON, Relative to When the Device is Turned OFF	4.5 months and 7.5 months	Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF during OFF - WVF during ON)/ (WVF during OFF))\*100%. A positive reduction represents an improvement in WVF when the device was ON.

Secondary Outcome Measures

Name	Time	Method
Percent Reduction in Symptom Score When the Device is Turned ON, Relative to When the Device is Turned OFF	4.5 months and 7.5 months	A symptom interview was conducted at each visit to assess vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain and epigastric burning. The scale for each symptom ranges from 0 to 4, with 0 being absence of symptoms and 4 being extremely frequent (≥ 7 episodes per week). Total symptom score (TSS) is the sum of the individual frequency symptom scores. The percent reduction is calculated as ((TSS during OFF - TSS during ON)/ (TSS during OFF))\*100%. A positive reduction represents an improvement in TSS when the device was ON.
Percent Reduction in the Frequency of Weekly Vomiting Episodes at 12 Months Compared to Baseline	baseline and 12 months	Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF at baseline - WVF at 12 months)/ (WVF at baseline))\*100%. A positive reduction represents an improvement in WVF at 12 months.