Indiana University Gastric Electrical Stimulation Registry

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Indiana University

Status

Invitation-only

Conditions

Gastroparesis

Study type

Observational

Funder types

Other

Identifiers

NCT05047289
2008529997

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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