Trials / Terminated
TerminatedNCT04121325
Gastric Electrical Stimulation for Abdominal Pain in Gastroparesis
Gastric Electrical Stimulation for Treating Abdominal Pain in Patients With Gastroparesis
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 4 (actual)
- Sponsor
- University of Louisville · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-12-18
- Primary completion
- 2020-03-13
- Completion
- 2020-03-13
- First posted
- 2019-10-09
- Last updated
- 2023-10-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04121325. Inclusion in this directory is not an endorsement.