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Gastric Electrical Stimulation for Abdominal Pain in Patients With Gastroparesis

A legfontosabb adatok

Hol
Louisville (Egyesült Államok)A helyszín megnézése

Helyszínek itt: Egyesült Államok

  • University of Louisville, Clinical Trials UnitLouisville, Egyesült ÁllamokContact: Thomas L Abell, MDNo longer taking part

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Contact the study team: see the registry record → Contacts and Locations

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A vizsgálat adatai

Ki végzi
University of Louisville
Azonosító
NCT07556237
A regiszteradat frissítve
2026. május 4.
Eredeti leírás
Gastroparesis is a disorder characterized by delayed gastric emptying and symptoms including nausea, vomiting, and abdominal pain. Gastric electrical stimulation (GES) using the implanted Enterra™ neurostimulator is FDA-approved to treat nausea and vomiting but its impact on abdominal pain has not been well studied. This study evaluates whether alternative programming parameters of the Enterra™ device can reduce abdominal pain in patients with gastroparesis. Participants with an existing Enterra™ device will be randomized to one of three stimulation settings and followed for assessment of pain, gastrointestinal symptoms, quality of life, and medication use.A teljes eredeti leírásKevesebb

Gastroparesis is a disorder characterized by delayed gastric emptying and symptoms including nausea, vomiting, and abdominal pain. Gastric electrical stimulation (GES) using the implanted Enterra™ neurostimulator is FDA-approved to treat nausea and vomiting but its impact on abdominal pain has not been well studied. This study evaluates whether alternative programming parameters of the Enterra™ device can reduce abdominal pain in patients with gastroparesis. Participants with an existing Enterra™ device will be randomized to one of three stimulation settings and followed for assessment of pain, gastrointestinal symptoms, quality of life, and medication use.

Bevonási feltételek: Adults aged 18 years or older; Diagnosed gastroparesis; Implanted Enterra™ device for at least 8 weeks prior to enrollment; Chronic daily abdominal pain of gastric origin lasting more than 2 months; Average pain score ≥4 on a 0-10 scale; Ability to provide informed consent.

Kizáró feltételek: Other medical conditions that would interfere with study participation; Severe constipation or uncontrolled diabetes (HbA1c >10); Daily opioid use; Pregnancy or breastfeeding; Abdominal pain not attributed to gastric/visceral origin.

ClinicalTrials.gov NCT07556237