Indiana University Gastric Electrical Stimulation Registry

Gastroparesis Clinical Trial

Official title:

Indiana University Gastric Electrical Stimulation Registry

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05047289
• Other study ID #: 2008529997
• Status: Enrolling by invitation
• Start date: October 20, 2020
• Est. completion date: October 20, 2030

Study information

• Verified date: April 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: October 20, 2030
• Est. primary completion date: October 20, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroparesis

Locations

Country	Name	City	State
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years