Gastric Electrical Stimulation for Abdominal Pain in Gastroparesis

University of Louisville (UOFL)

Status: Terminated

Conditions: Abdominal Pain

Treatments: Device: Enterra

Study type: Observational

Funder types: Other

Identifiers

NCT04121325

19.0915

Details and patient eligibility

About

To conduct a pilot study to evaluate the effects of new GES programming settings on abdominal pain in patients with gastroparesis and existing GES devices, whose abdominal pain has so far been refractory to drugs and/or devices.

Full description

Eligible patients will undergo detailed pain assessments as well as non-invasive physiologic assessment. Patients existing GES devices will be reprogrammed to new setting for 4 week and their GI symptoms including pain will be evaluated by a daily diary. At the end of 4 weeks detailed pain assessments and noninvasive physiologic assessments will be repeated.

Enrollment: 4 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Should be able to give informed consent for the study
• Has Enterra GES device in place for at least 2 months
• Continue to have moderate to severe abdominal pain on at least one pain questionnaire or >5 score (on a scale of 0-10 for pain) on the VAS questionnaire for at least 2 months.
• Abdominal pain should be either persistent; for example, daily for at least >1 hour, be chronic for >2 months, and refractory to original Enterra GES settings

Exclusion criteria

• Unable to provide informed consent
• Pregnancy
• Any other active health problems that would render patient unable to complete the study

Trial design

4 participants in 1 patient group

Gastroparesis patients with abdominal pain

Description:

Patients with gastroparesis who have had an Enterra device in place for at least two months who continue to have moderate to severe abdominal pain.

Treatment:

Device: Enterra