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Laparoscopic Implantation of a Gastric Pacemaker in the Treatment of Gastroparesis

NCT06661668 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-08-12

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Gastric pacemaker (Enterra system) implantation

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

Sponsors & Collaborators

  • Enterra Medical, Inc.

    collaborator INDUSTRY

  • Evangelic Hospital Kalk Cologne

    lead OTHER

Principal Investigators

  • Jessica M Leers, Prof. · Department of Functional Upper GI Surgery

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06661668 on ClinicalTrials.gov