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Clinical evidence

Proven, powerful relief

20 years of clinical studies of Gastric Electrical Stimulation (GES) with Enterra Therapy have shown meaningful reduction in nausea and vomiting symptoms in patients with diabetic and idiopathic gastroparesis.

See if your patient is a candidate

Studies demonstrate significant improvements in patient symptoms, hospitalization, and quality of life.

80%

patient
satisfaction

5 years with
Enterra Therapy1

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91%

reduction in hospitalization events

1 year with
Enterra Therapy1

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68%

reduction in vomiting frequency

up to 12 months among patients with diabetic gastroparesis2

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87%

reduction in vomiting frequency

up to 12 months among patients with idiopathic gastroparesis3

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STATISTICALLY SIGNIFICANT

IMPROVEMENT

IN VOMITING
FREQUENCY SCORE

during therapy
ON vs. OFF period4

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Double-blind RCT

NAVIGATE Indication expansion

Goal: Determine effectiveness of Enterra Therapy on non-gastroparetic patients

Rationale: Several other patient populations, such as functional dyspepsia, experience chronic nausea and vomiting, and could potentially benefit from gastric electrical stimulation with Enterra Therapy

View study
3-Arm, Single-blind, non-inferiority RCT

RESTING Battery longevity

Goal: Determine whether battery life can be extended by turning off stimulation during nighttime

Rationale: Patients may benefit from longer battery life, fewer device replacements, and potential for smaller devices

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Single-blind RCT

EXPEDITE Programming

Goal: Determine if setting initial stimulation parameters to a higher setting results in better patient outcomes

Rationale: Patients currently undergo titration phase, where stimulation gradually increases to find optimal settings. This phase may be skipped or expedited in the future

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Enterra Therapy is approved by the FDA under a Humanitarian Device Exemption for use in drug-refractory gastroparesis. The uses evaluated in the studies above have not been approved or cleared by the FDA and are considered investigational. These investigational uses are available only to patients enrolled by physicians participating in each study, under that study’s protocol and Institutional Review Board oversight. Enrollment does not guarantee any clinical benefit

Active clinical studies

Double-blind RCT

NAVIGATE Indication expansion

Goal: Determine effectiveness of Enterra Therapy on non-gastroparetic patients

Rationale: Several other patient populations, such as functional dyspepsia, experience chronic nausea and vomiting, and could potentially benefit from gastric electrical stimulation with Enterra Therapy

View study
3-Arm, Single-blind, non-inferiority RCT

RESTING Battery longevity

Goal: Determine whether battery life can be extended by turning off stimulation during nighttime

Rationale: Patients may benefit from longer battery life, fewer device replacements, and potential for smaller devices

View study
Single-blind RCT

EXPEDITE Programming

Goal: Determine if setting initial stimulation parameters to a higher setting results in better patient outcomes

Rationale: Patients currently undergo titration phase, where stimulation gradually increases to find optimal settings. This phase may be skipped or expedited in the future

View study

Enterra Therapy is approved by the FDA under a Humanitarian Device Exemption for use in drug-refractory gastroparesis. The uses evaluated in the studies above have not been approved or cleared by the FDA and are considered investigational. These investigational uses are available only to patients enrolled by physicians participating in each study, under that study’s protocol and Institutional Review Board oversight. Enrollment does not guarantee any clinical benefit

Prospective

Effectiveness of gastric electrical stimulation in gastroparesis

(2019)

Abell et al.

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Prospective

Surgical treatment for refractory gastroparesis: stimulator, pyloric surgery, or both?

(2020)

Zoll et al.

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Prospective

Tailored approach to gastroparesis significantly improves symptoms

(2018)

Arthur et al.

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Additional clinical studies

Prospective

Effectiveness of gastric electrical stimulation in gastroparesis

(2019)

Abell et al.

View study
Prospective

Surgical treatment for refractory gastroparesis: stimulator, pyloric surgery, or both?

(2020)

Zoll et al.

View study
Prospective

Tailored approach to gastroparesis significantly improves symptoms

(2018)

Arthur et al.

View study

Practice guidelines for GES

AGA Clinical Practice Guidelines (2025)

“As part of shared decision making and depending on clinical presentation, clinicians and patients may reasonably elect to undergo procedures: botulinum toxin injection, GPOEM, or gastric electrical stimulator”5

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ACG guidelines (2022)

“Gastric electric stimulation (GES) may be
considered for control of gastroparesis
symptoms as a humanitarian use device (HUD).”6

Read more

NEXT: Patient selection & referral

  1. Cassidy DJ, Gerull W, Zike VM, Awad MM. Clinical Outcomes of a Large, Prospective Series of Gastric Electrical Stimulation Patients Using a Multidisciplinary Protocol. J Am Coll Surg. April 2024.
  2. 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. 
  3. 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. *Manufacture sponsored study. Cross-over periods showed a non-significant reduction in vomiting in the ON vs. OFF period. 
  4. 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.
  5. Staller K, Camilleri M, Kuo B, et al. AGA Clinical Practice Guideline on Management of gastroparesis. Gastroenterology. 2025;169(5):828-861. doi:10.1053/j.gastro.2025.08.023.
  6. Camilleri, et al. ACG Clinical Guidelines: Gastroparesis. Am J Gastroenterol. 2022 Aug 1;117(8):1197-1220. doi: 10.14309/ajg.0000000000001874.
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?