Enhanced programming stimulation for gastroparesis treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research evaluates whether an enhanced programming strategy for the Enterra Therapy System can improve symptoms of gastroparesis more quickly and enhance quality of life. Participants will have the device implanted and will be randomly assigned to one of two programming strategies. They will track their symptoms daily using a mobile application and complete quality of life questionnaires during monthly visits. The study will last up to six months post-treatment assignment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Completed informed consent process with signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged ≥18 or ≤70 years at time of Enterra® therapy implantation
4. Diagnosed with idiopathic or diabetic gastroparesis
5. Delayed solid-phase gastric emptying study (Eggbeaters™ test meal), completed within one year of patient enrollment in the study. Gastroparesis defined as \> 60% retained at 2 hours and/or \>10% retained at 4 hours
6. Investigator confirms normal endoscopy within one year of enrollment in the study
7. GCSI-DD score for nausea severity during the qualifying Baseline Period averaging 2.5 or more per week and vomiting averaging 5 or more episodes per week

Exclusion Criteria:

1. Post-surgical gastroparesis (e.g., fundoplication, Billroth I or II) or other active stomach or gastrointestinal diseases disorders which could explain symptoms in the opinion of the investigator
2. History of pyloroplasty or pyloromyotomy or G-POEM
3. Pregnancy or breastfeeding at the time of consent, or intent to become pregnant during the study
4. Active H. pylori infection
5. Significant hepatic injury (elevated ALT, AST, bilirubin)
6. Metabolic, mechanical, or mucosal inflammatory causes that may explain GI symptoms such as gallbladder disease, small bowel bacterial overgrowth, IBS, inflammatory bowel disease, celiac disease, liver or pancreatic disease, or bowel obstruction
7. Patients with significant cardiac or cardiovascular disease, malignancy, or other conditions
8. Participation in other clinical studies
9. Use of narcotics more than three days per week or other drugs that may affect motility (e.g., Glucagon-like peptide 1 (GLP-1) agonist drug)
10. Cannabis and/or cannabinoid use that exceeds either:

    1. Greater than 3 days of usage per week with 2 or less occurrences each day of use, or
    2. Greater than 3 grams of total usage per week
11. Previous diagnosis or history of orthostatic intolerance, e.g., POTS, neurocardiogenic syncope, orthostatic hypotension
12. Subject experiences discomfort during stimulation assessment that cannot be tolerated
13. Subjects with an underlying disease leading to follow-up by MRI outside of current MR conditional indications
14. Evidence of a failed response to temporary gastric electrical stimulation

Where it's running

• University of South Florida
  Tampa, Florida, United States Recruiting
• University of Louisville
  Louisville, Kentucky, United States Recruiting
• Henry Ford Health System
  Detroit, Michigan, United States Recruiting
• Washington University
  St Louis, Missouri, United States Recruiting
• Foundation for Surgical Innovation
  Portland, Oregon, United States Recruiting
• Benaroya Research Institute at Virginia Mason
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Michael Awad, MD, PhD — Washington University School of Medicine
• Study coordinator: Timothy McAllister
• Email: clinicalresearch@enterramedical.com
• Phone: 855-768-3772

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating Enterra Device Programming for Gastroparesis Relief During Sleep

  This study is testing different ways to program the Enterra® device at night to see if it helps people with gastroparesis feel better while they sleep.

  Recruiting at 2 sites Enterra Medical, Inc. · Louisville, Kentucky and 1 other locations · NCT05980455

• Implanting a gastric pacemaker to treat gastroparesis

  This study is testing whether a gastric pacemaker can help people with severe gastroparesis who haven't found relief from other treatments by improving their stomach function and reducing symptoms like nausea and bloating.

  Recruiting Evangelic Hospital Kalk Cologne · Cologne, North Rhine-Westphalia · NCT06661668

• Registry for patients with gastroparesis and functional dyspepsia

  This study is trying to learn more about people with gastroparesis and functional dyspepsia by collecting information on their symptoms and experiences over 48 weeks.

  Recruiting at 6 sites Johns Hopkins Bloomberg School of Public Health · Scottsdale, Arizona and 5 other locations · NCT05846802

• Gastric-focused ultrasound to see if it changes stomach activity and symptoms

  This study tests whether noninvasive stomach-focused ultrasound can alter post-meal stomach electrical activity and symptoms in adults with gastroparesis or delayed gastric emptying, using a sham control in a crossover design.

  Recruiting University of Texas at Austin · Austin, Texas · NCT07851727

• Gastric emptying and feeding tolerance in ICU patients by vasopressor dose

  This study tests whether vasopressor dose affects how well stomach contents empty during tube feeding in critically ill patients.

  Recruiting Başakşehir Çam & Sakura City Hospital · Istanbul · NCT07802379

• Virtual poetry workshops to boost well-being for people with digestive symptoms

  This study tests whether participating in online poetry workshops can improve emotional well-being for adults with chronic digestive symptoms and anxiety or depression.

  Recruiting Ohio State University · Columbus, Ohio · NCT07717541

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.