Laparoscopic Implantation of a Gastric Pacemaker in the Treatment of Gastroparesis

Recruiting now

Conditions studied: Gastroparesis, Gastroparesis Postoperative, Gastroparesis Nondiabetic, Gastroparesis With Diabetes Mellitus

In brief

Gastroparesis is a burdensome condition that is caused by abnormal motor function of the stomach that results in delayed gastric emptying. It typically manifests with bloating, nausea, vomiting, abdominal pain, and even excessive weight loss and dehydration. The most common causes of gastroparesis are idiopathic, diabetic, medication-induced or iatrogenic (postsurgical) gastroparesis. Implantation of a gastric neurostimulation device is a surgical option to improve gastric emptying in patients with medication-refractory gastroparesis. Enterra® system is a gastric electrical stimulation that sends mild pulses through leads implanted in the stomach wall that stimulate gastric smooth muscles and nerves in order to improve symptoms and quality of life. Aim of the investogators' registry trial is to evaluate the feasibility and efficacy of laparoscopic gastric pacemaker implantation for electrical stimulation (Enterra® system). Primary endpoints of the study are symptom severity, health-related quality of life, and frequency of hospitalization before and after pacemaker implantation, perioperative complication rate, and cost effectiveness.

Key facts

Study ID

NCT06661668

Run by

Evangelic Hospital Kalk Cologne

People needed

50

Starts

2023-01-01

Expected to finish

2026-12-31

Last updated by the study team

2025-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Scintigraphically proven gastroparesis
• Failed conservative therapy
• Severe impairment of quality of life
• Written informed consent
• German language

You may not qualify if…

• Age < 18 years
• Prior gastric resection

Where it is running

• Department of Functional Upper GI Surgery — Cologne, North Rhine-Westphalia, Germany (enrolling)

Full record on ClinicalTrials.gov

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