Gastroparesis study: Enterra Therapy System
Official title Study of Enhanced Programming Stimulation with the Enterra® Therapy System
ClinicalTrials.gov ID: NCT06560307
What this study is testing
- What it's testing
- The study will find out whether an enhanced programming strategy for the Enterra Therapy System improves gastroparesis symptoms more quickly and boosts quality of life.
- Who it's for
- Adults with gastroparesis (including diabetic and non‑diabetic) who are eligible for an Enterra implant.
- What's involved
- Participants will have the Enterra Therapy System implanted, be randomly assigned to one of two programming settings, answer daily symptom questions on a phone or tablet app, and complete quality‑of‑life questionnaires at monthly visits.
- Time commitment
- The study lasts up to six months after the programming assignment, with monthly clinic visits and daily app entries.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Completed informed consent process with signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥18 or ≤70 years at time of Enterra® therapy implantation
- Diagnosed with idiopathic or diabetic gastroparesis
- Delayed solid-phase gastric emptying study (Eggbeaters™ test meal), completed within one year of patient enrollment in the study.
You likely can't join if
- Post-surgical gastroparesis (e.g., fundoplication, Billroth I or II) or other active stomach or gastrointestinal diseases disorders which could...
- History of pyloroplasty or pyloromyotomy or G-POEM
- Pregnancy or breastfeeding at the time of consent, or intent to become pregnant during the study
- Active H. pylori infection
- Significant hepatic injury (elevated ALT, AST, bilirubin)
- Metabolic, mechanical, or mucosal inflammatory causes that may explain GI symptoms such as gallbladder disease, small bowel bacterial overgrowth...
See the full eligibility criteria
- Completed informed consent process with signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥18 or ≤70 years at time of Enterra® therapy implantation
- Diagnosed with idiopathic or diabetic gastroparesis
- 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
- Investigator confirms normal endoscopy within one year of enrollment in the study
- 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
- 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
- History of pyloroplasty or pyloromyotomy or G-POEM
- Pregnancy or breastfeeding at the time of consent, or intent to become pregnant during the study
- Active H. pylori infection
- Significant hepatic injury (elevated ALT, AST, bilirubin)
- 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...
- Patients with significant cardiac or cardiovascular disease, malignancy, or other conditions
- Participation in other clinical studies
- 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)
- Greater than 3 days of usage per week with 2 or less occurrences each day of use, or
- Greater than 3 grams of total usage per week
- Previous diagnosis or history of orthostatic intolerance, e.g., POTS, neurocardiogenic syncope, orthostatic hypotension
- Subject experiences discomfort during stimulation assessment that cannot be tolerated
- people with an underlying disease leading to follow-up by MRI outside of current MR conditional indications
- Evidence of a failed response to temporary gastric electrical stimulation
The study team makes the final eligibility decision.
Where it is enrolling
- Tampa, Florida, United States
- Louisville, Kentucky, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- Portland, Oregon, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tampa, Florida, United States; Louisville, Kentucky, United States; Detroit, Michigan, United States; St Louis, Missouri, United States; Portland, Oregon, United States; Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.