Indiana University Gastric Electrical Stimulation Registry

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05047289

Enrollment

1000

Registered

2021-09-17

Start date

2020-10-20

Completion date

2030-10-20

Last updated

2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroparesis

Keywords

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

Brief 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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patients undergo implantation of a new GES device for medical refractory gastroparesis

Exclusion criteria

* Non-ambulatory patients: bed-ridden, nursing home resident, etc. * Pregnancy * Unable to give own informed consent. * Prisoners

Design outcomes

Primary

Measure	Time frame	Description
To develop a clinical registry in patients with GES therapy	3 years	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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJohn Wo, MD

Indiana University

Outcome results