NCT06661668 Laparoscopic Implantation of a Gastric Pacemaker in the Treatment of Gastroparesis
| NCT ID | NCT06661668 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Evangelic Hospital Kalk Cologne |
| Condition | Gastroparesis |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2023-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Scintigraphically proven gastroparesis * Failed conservative therapy * Severe impairment of quality of life * Written informed consent * German language Exclusion Criteria: * Age \< 18 years * Prior gastric resection
Contact & Investigator
Jessica M Leers, Prof.
PRINCIPAL INVESTIGATOR
Department of Functional Upper GI Surgery
Frequently Asked Questions
Who can join the NCT06661668 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastroparesis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06661668 currently recruiting?
Yes, NCT06661668 is actively recruiting participants. Contact the research team at jessica.leers@uk-koeln.de for enrollment information.
Where is the NCT06661668 trial being conducted?
This trial is being conducted at Cologne, Germany.
Who is sponsoring the NCT06661668 clinical trial?
NCT06661668 is sponsored by Evangelic Hospital Kalk Cologne. The principal investigator is Jessica M Leers, Prof. at Department of Functional Upper GI Surgery. The trial plans to enroll 50 participants.