Gastric Electrical Stimulation for Abdominal Pain in Gastroparesis
This study is looking at whether different settings for the Enterra™ neurostimulator can help reduce chronic abdominal pain in people with gastroparesis (a condition where your stomach empties too slowly, causing symptoms like nausea and pain). The Enterra™ device is already approved to treat nausea and vomiting, but its effect on pain isn't well understood. You might be able to join if you are an adult aged 18 or older, have been diagnosed with gastroparesis, already have an Enterra™ device implanted for at least 8 weeks, and experience daily abdominal pain of gastric origin with an average pain score of 4 or higher. The main goal is to see how much your abdominal pain score changes from the beginning of the study to 8 weeks later. The current recruitment status is unclear.
- Study design
- This is a randomized, double-blind study where participants are assigned to one of three Enterra™ device settings. About 150 people are expected to join.
- What's involved
- You would first use your current device settings for two weeks. Then, you would use your assigned study settings for eight weeks, during which you'd report on your pain, symptoms, quality of life, and medication use.
- Compensation
- Not stated in the trial record.
- Follow-up
- After the 8-week blinded assessment, you may choose your preferred settings for an additional 8-week follow-up period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Gastric Electrical Stimulation for Abdominal Pain in Patients With Gastroparesis
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in Abdominal Pain ScoreBaseline to 8 weeks after randomization.
Change from baseline in seven-day average of daily worst abdominal pain score measured using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst possible pain).