Laparoscopic Implantation of a Gastric Pacemaker in the Treatment of Gastroparesis
NCT ID: NCT06661668
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2023-01-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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After ruling out mechanical obstruction as an underlying cause of gastroparesis using endoscopy or computed tomography, further assessment includes gastric emptying studies by scintigraphy to confirm the presence of delayed gastric emptying. Severity of symptoms and impact on health-related quality of life can be assessed using the Gastroparesis Cardinal Symptom Index (GCSI) and Gastrointestinal Quality of Life Index (GIQLI).
Management of gastroparesis includes assessment of nutritional status, correction of fluid, electrolytes and nutritional deficiencies, symptomatic therapy, management of the underlying cause of gastroparesis, and improvement of gastric emptying. 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 this 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.
It is hypothesized that implantation of the Enterra systems leads to a significant improvement of symptoms as well as an increase in health-related quality of life in patients with gastroparesis.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Gastroparesis group
Patients scintigraphically proven gastroparesis and failed conservative therapy who undergo laparoscopic gastric pacemaker implantation
Gastric pacemaker (Enterra system) implantation
Laparascopic implantation of a gastric pacemaker (Enterra system) for patients with therapy refractive gastroparesis
Interventions
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Gastric pacemaker (Enterra system) implantation
Laparascopic implantation of a gastric pacemaker (Enterra system) for patients with therapy refractive gastroparesis
Eligibility Criteria
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Inclusion Criteria
* Failed conservative therapy
* Severe impairment of quality of life
* Written informed consent
* German language
Exclusion Criteria
* Prior gastric resection
18 Years
ALL
No
Sponsors
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Enterra Medical, Inc.
INDUSTRY
Evangelic Hospital Kalk Cologne
OTHER
Responsible Party
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Jessica Leers
Prof. Dr. med. Jessica Leers
Principal Investigators
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Jessica M Leers, Prof.
Role: PRINCIPAL_INVESTIGATOR
Department of Functional Upper GI Surgery
Locations
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Department of Functional Upper GI Surgery
Cologne, North Rhine-Westphalia, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Gastroparesis_Enterra
Identifier Type: -
Identifier Source: org_study_id
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