Laparoscopic Implantation of a Gastric Pacemaker in the Treatment of Gastroparesis

Sponsor
Evangelic Hospital Kalk Cologne
Study ID
NCT06661668
Status
Recruiting
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Conditions

  • Gastroparesis
  • Gastroparesis Nondiabetic
  • Gastroparesis Postoperative
  • Gastroparesis With Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gastric pacemaker (Enterra system) implantation — DEVICE
    Laparascopic implantation of a gastric pacemaker (Enterra system) for patients with therapy refractive gastroparesis

Study Details

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 Dates

First listed
Oct 28, 2024
Start date
Jan 1, 2023
Status verified
Oct 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Gastroparesis group
    Patients scintigraphically proven gastroparesis and failed conservative therapy who undergo laparoscopic gastric pacemaker implantation

Primary Outcome Measure

Symptoms [ Time Frame: 5 years ]

Central Contacts

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