Laparoscopic Implantation of a Gastric Pacemaker in the Treatment of Gastroparesis

NCT06661668 | Recruiting DMC FDA Device

• 1 other identifier: Gastroparesis_Enterra
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gastroparesis; Gastric pacemaker

Outcome Measures

Primary Outcomes (2)

• Symptoms

  Symptom severity/Improvement of symptoms pre-/post gastric pacemaker implantation using the standardized Gastroparesis Cardinal Symptom Index (GCSI). The GCSI is based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). A total score of 45 can be achieved. A high score indicates more severe symptoms.

  5 years

• Health-related quality of life

  Health-related quality of life pre-/post gastric pacemaker implantation using the GIQLI questionnaire (Gastrointestinal Quality of Life Index). GIQLI is a validated instrument to assess HRQoL among patients with gastrointestinal disorders. The questionnaire consists of 36 questions and is subdivided into five subcategories (symptoms, emotion, physical function, social function, and medical treatment). Total scores between 0 and 144 can be achieved. Respective total scores for the specific subcategories are symptoms=76, emotions=20, physical=28, and social=20. Higher scores represent a higher HRQoL.17

  5 years

Secondary Outcomes (2)

• Hospital admission

  5 years

• Perioperative complication rate

  1 year

Study Arms (1)

Gastroparesis group

Patients scintigraphically proven gastroparesis and failed conservative therapy who undergo laparoscopic gastric pacemaker implantation

Device: Gastric pacemaker (Enterra system) implantation

Interventions

Gastric pacemaker (Enterra system) implantation DEVICE

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

Gastroparesis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study includes patients with (1) scintigraphically proven gastroparesis, (2) failed conservative therapy, (3) who undergo laparoscopic gastric pacemaker implantation.

You may qualify if:

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

You may not qualify if:

• Age \< 18 years
• Prior gastric resection

Sponsors & Collaborators

• Evangelic Hospital Kalk Cologne: lead
• Enterra Medical, Inc.: collaborator

Study Sites (1)

Department of Functional Upper GI Surgery

Cologne, North Rhine-Westphalia, 51103, Germany

RECRUITING

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jessica M Leers, Prof.

  Department of Functional Upper GI Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica M Leers, Prof.

CONTACT

+49 221; jessica.leers@uk-koeln.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Jessica Leers

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: October 28, 2024
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 12, 2025

Record last verified: 2024-10

Locations

DE (1)