Gastric Electrical Stimulation for Abdominal Pain in Gastroparesis

Abdominal Pain Clinical Trial

Official title:

Gastric Electrical Stimulation for Treating Abdominal Pain in Patients With Gastroparesis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04121325
• Other study ID #: 19.0915
• Status: Terminated
• Start date: December 18, 2019
• Est. completion date: March 13, 2020

Study information

• Verified date: October 2023
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain
• Gastroparesis

Intervention

Device:
• Enterra
To measure validated and subjective pain scores among patients with an existing GES device, and who have a trial of new settings directed at abdominal pain and compare their pain scores to each patient baseline symptoms, done with their previous GES settings.

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal Pain	Abdominal Pain by Brief Pain Inventory. The values are 0-10, with 10 being worse outcome.	4 weeks