Clinical evidence
Designed to deliver durable relief from nausea & vomiting
A number of key clinical studies involving diabetic and idiopathic gastroparesis patients receiving Enterra™Therapy resulted in significant nausea and vomiting symptom improvements.
US control trial: diabetic gastroparesis1
Objective
This trial examined the safety and efficacy of Enterra Therapy in the treatment of chronic, intractable (drug-refractory) nausea and vomiting secondary to gastroparesis of diabetic etiology.
Design
Prospective, multi-center, double-blinded, 1:1 randomized controled trial with cross-over study design across 8 centers in the United States.
Endpoints
Weekly Vomiting Frequency (WVF); post crossover ON phase relative to OFF phase.
Results
- In a study of 55 diabetic gastroparetic patients, Enterra Therapy significantly reduced median WVF at 12 month follow-up.
- Crossover periods showed a non-significant reduction in vomiting in the ON vs. OFF period which may have been due to the lack of washout effect of 6 weeks of stimulation that took place pre-randomization.
- Enterra Therapy significantly reduced other key endpoints of total symptom scores and number of days hospitalized at 12 months.
Median Weekly Vomiting Frequency (WVF)
Total symptom score – severity
Hospitalization days
US control trial: idiopathic gastroparesis2
Objective
This trial examined the safety and efficacy of Enterra Therapy in the treatment of chronic, intractable (drug-refractory) nausea and vomiting secondary to gastroparesis of idiopathic etiology.
Design
Prospective, multi-center, double-blinded, 1:1 randomized controlled trial with cross-over study design across 6 centers in the United States.
Primary endpoint
Weekly vomiting frequency (WVF); post crossover ON phase relative to OFF phase.
Results
- In a study of 32 idiopathic gastroparetic patients, Enterra Therapy significantly reduced median WVF at 12 month follow-up.
- Crossover periods showed a non-significant reduction in vomiting in the ON vs. OFF period which may have been due to the lack of washout effect of 6 weeks of stimulation that took place pre-randomization.
- Enterra Therapy significantly reduced key secondary endpoints of Total Symptom Scores and number of days hospitalized at 12 months.
Median Weekly Vomiting Frequency (WVF)
Total symptom score – severity
Hospitalization days
French ministry of health-sponsored randomized control trial3
Objective
This independent study conducted by the French Ministry of Health examined efficacy of Enterra Therapy in the treatment of chronic, intractable nausea and vomiting, with or without gastroparesis.
Design
Prospective, large, multi-center, double-blinded, 1:1 randomized trial with cross-over study design across 19 centers in France.
Primary endpoint
Vomiting Score (measured 0-4 numeric scale), QOL.
Results
- This study, the largest RCT conducted on Enterra Therapy to date, showed statistically significant improvement in symptoms at 9 months.
- A portion of the study subjects were off-label, and the results for those patients are not presented here.
Trial-specific vomiting score
(Higher score represents improved symptoms)
| Scoring | Frequency of vomiting |
|---|---|
| 0 | Several vomiting episodes a week |
| 1 | No more than 1 vomiting episodes a week |
| 2 | At least 1 vomiting episode a month |
| 3 | Less than 1 vomiting episodes a month |
| 4 | No vomiting episode |
Long-term 10-year outcomes study4
Objective
This study examined the long-term (>10 years) safety and efficacy of Enterra Therapy in patients with intractable nausea and vomiting.
Design
Retrospective, single-center French study examining 50 consecutive patients with refractory chronic nausea and/or vomiting lasting at least 12 months (failure of 2 prokinetics and antiemetics) implanted with gastric electrical stimulator.
Primary endpoint
- Gastrointestinal Quality of Life Index (GIQLI) score.
- Primary outcome was reduction in nausea and/or vomiting using a 5-point score.
- Reduction in nausea and/or vomiting by 1 point, defined as >50% reduction in frequency.
Results
- In a retrospective study of 50 patients, Enterra Therapy significantly improved primary endpoint of nausea and vomiting in 54% of patients by greater than 50% at 10 years.
- Enterra Therapy significantly improved primary endpoint of Gastrointestinal QOL Index (GIQLI) score and patients reported high level of satisfaction (80%) with the therapy at 10 years.
Nausea
Vomiting
Gastrointestinal quality of life index (GIQLI) score
Median overall GIQLI patient satisfaction score
Additional clinical studies
Surgical treatment for refractory gastroparesis: stimulator, pyloric surgery, or both?
(2020)
Zoll et al.
Enterra Therapy supported by practice guidelines
AGA best practices review (2021)
“Enterra Therapy does improve refractory nausea and vomiting in some patients with gastroparesis and may improve glycemic control, nutritional status, and quality of life, while reducing hospitalizations and medication use.”5
ACG practice guidelines (2013)
“Conditional recommendation, moderate level of evidence, may be considered for compassionate use in patients with refractory symptoms, particularly nausea and vomiting.”6
- McCallum RW, Snape W, Brody F, Wo J, Parkman HP, Nowak T. Gastric electrical stimulation with Enterra therapy improves symptoms from diabetic gastroparesis in a prospective study. Clin Gastroenterol Hepatol. 2010;8(11):947-e116. doi:10.1016/j.cgh.2010.05.020.
- McCallum RW, Snape W, Brody F, Wo J, Parkman HP, Nowak T. Gastric electrical stimulation with Enterra therapy improves symptoms of idiopathic gastroparesis. Neurogastroenterol Motil (2013) 25, 815–e636.
- Ducrotte P, Coffin B, Bonaz B, et al. Gastric Electrical Stimulation Reduces Refractory Vomiting in a Randomized Crossover Trial. Gastroenterology. 2020;158(3):506-514.e2. doi:10.1053/j.gastro.2019.10.018.
- Hedjoudje A, Huet E, Leroi AM, Desprez C, Melchior C, Gourcerol G. Efficacy of gastric electrical stimulation in intractable nausea and vomiting at 10 years: A retrospective analysis of prospectively collected data. Neurogastroenterol Motil. 2020;32(11):e13949. doi:10.1111/nmo.13949.
- Lacy BE, Tack J, Gyawali CP. AGA Clinical Practice Update on Management of Medically Refractory Gastroparesis: Expert Review [published online ahead of print, 2021 Oct 29]. Clin Gastroenterol Hepatol. 2021;S1542 3565(21)01151 4. doi:10.1016/j.cgh.2021.10.038.
- Camilleri M, Parkman HP, Shafi MA, et al. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013;108:18-37.
MKT-D-0006, Rev E
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?