Implanting a gastric pacemaker to treat gastroparesis
Laparoscopic Implantation of a Gastric Pacemaker is a Low-complication Alternative for Gastroparesis
Evangelic Hospital Kalk Cologne · NCT06661668
This study is testing whether a gastric pacemaker can help people with severe gastroparesis who haven't found relief from other treatments by improving their stomach function and reducing symptoms like nausea and bloating.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Evangelic Hospital Kalk Cologne (other) |
| Locations | 1 site (Cologne, North Rhine-Westphalia) |
| Trial ID | NCT06661668 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the feasibility and efficacy of laparoscopic implantation of a gastric pacemaker, known as the Enterra® system, for patients suffering from medication-refractory gastroparesis. The trial focuses on patients with confirmed delayed gastric emptying who have not responded to conservative treatments. By using electrical stimulation to improve gastric motility, the study aims to alleviate symptoms such as nausea, bloating, and abdominal pain, thereby enhancing the quality of life for affected individuals. The primary endpoints include symptom severity and health-related quality of life assessments.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with scintigraphically proven gastroparesis who have failed conservative therapy and experience severe impairment in their quality of life.
Not a fit: Patients under 18 years of age or those who have undergone prior gastric resection are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients with severe gastroparesis who have not found relief through other treatments.
How similar studies have performed: Previous studies involving gastric electrical stimulation have shown promising results, indicating that this approach may be effective for treating gastroparesis.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cologne, North Rhine-Westphalia
- Department of Functional Upper GI Surgery — Cologne, North Rhine-Westphalia, Germany (RECRUITING)
Study contacts
- Principal investigator: Jessica M Leers, Prof. — Department of Functional Upper GI Surgery
- Study coordinator: Jessica M Leers, Prof.
- Email: jessica.leers@uk-koeln.de
- Phone: +49 221
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastroparesis, Gastroparesis Postoperative, Gastroparesis Nondiabetic, Gastroparesis With Diabetes Mellitus, Gastric pacemaker