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Enrolling by invitationNCT05047289Updated Jun 16, 2026

Indiana University Gastric Electrical Stimulation Registry

An observational study in Gastroparesis, sponsored by Indiana University. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Indiana University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to develop a clinical registry in patients with Gastric Electrical Stimulation (GES) therapy for gastroparesis to support future gastrointestinal therapies, medical procedures and diagnostics.

Read the detailed description

This study will evaluate male and female patients at least 18 years of age, with gastroparesis, who will or have already undergone the implantation of a GES device

The study will be conducted at one center and approximately 1,000 subjects will be enrolled.

Subjects undergoing the GES implantation will be enrolled before the implantation and may have a baseline visit. The visit procedures will be conducted at the discretion of the investigator dependent on the clinical condition of the patient at that time.

02

Conditions studied

  • Gastroparesis

Keywords

  • gastroparesis
  • gastric electrical stimulator
  • GES
  • vomiting
  • nausea
  • bloating
  • post prandial fullness
  • epigastric pain
03

In context

Gastroparesis

323 studies on the registry are indexed under Gastroparesis; 76 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 100 across 80 observational studies indexed under Gastroparesis.

Browse Gastroparesis studies →

Lead sponsor

Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.

Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study will evaluate male and female patients at least 18 years of age, with gastroparesis, who will or have already undergone the implantation of a GES device (Enterra, Medtronic, Minneapolis, MN)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergo implantation of a new GES device for medical gastroparesis

Exclusion criteria

Exclusion Criteria:

  • Non-ambulatory patients: bed-ridden, nursing home resident, etc.
  • Pregnancy
  • Unable to give own .
  • Prisoners
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. To develop a clinical registry in patients with GES therapy

    The purpose of this study is to develop a clinical registry in patients with Gastric Electrical Stimulation (GES) therapy for gastroparesis to support future clinical and translational research. Gastroparesis is an illness caused by a delay of stomach emptying. Symptoms of gastroparesis include nausea, vomiting, weight loss, the feeling of being full right away when you start eating, and abdominal pain. The disease may also lead to malnutrition and weight loss. GES has shown promise in patients with gastroparesis. However, how the GES works is unclear, but the patients who undergo GES show improvement in their symptoms.

    Time frame: 3 years

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05047289
Lead sponsor
Indiana University
Collaborators
Purdue University
Responsible party
John M. Wo (Director, GI Motility and Neurogastroenterology, Indiana University) — Principal investigator
First posted
Sep 17, 2021
Start date
Oct 20, 2020
Primary completion
Oct 20, 2030 (estimated)
Completion
Oct 20, 2030 (estimated)
Last update
Jun 16, 2026

Study contacts

John Wo, MD
principal investigator · Indiana University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

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