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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
View:

• Scintigraphically proven gastroparesis

• Failed conservative therapy

• Severe impairment of quality of life

• Written informed consent

• German language

Locations
Other Locations
Germany
Department of Functional Upper GI Surgery
RECRUITING
Cologne
Contact Information
Primary
Jessica M Leers, Prof.
jessica.leers@uk-koeln.de
+49 221
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 50
Treatments
Gastroparesis group
Patients scintigraphically proven gastroparesis and failed conservative therapy who undergo laparoscopic gastric pacemaker implantation
Related Therapeutic Areas
Sponsors
Collaborators: Enterra Medical, Inc.
Leads: Evangelic Hospital Kalk Cologne

This content was sourced from clinicaltrials.gov