RecruitingNCT06661668

Laparoscopic Implantation of a Gastric Pacemaker in the Treatment of Gastroparesis

Laparoscopic Implantation of a Gastric Pacemaker is a Low-complication Alternative for Gastroparesis


Sponsor

Evangelic Hospital Kalk Cologne

Enrollment

50 participants

Start Date

Jan 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

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

Exclusion Criteria2

  • Age < 18 years
  • Prior gastric resection

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEGastric pacemaker (Enterra system) implantation

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


Locations(1)

Department of Functional Upper GI Surgery

Cologne, North Rhine-Westphalia, Germany

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06661668


Related Trials