Actively Recruiting
Laparoscopic Implantation of a Gastric Pacemaker is a Low-complication Alternative for Gastroparesis
Led by Evangelic Hospital Kalk Cologne · Updated on 2025-08-12
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
E
Evangelic Hospital Kalk Cologne
Lead Sponsor
E
Enterra Medical, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Gastroparesis is a challenging condition caused by abnormal stomach movement that delays gastric emptying, leading to symptoms like bloating, nausea, vomiting, abdominal pain, weight loss, and dehydration. It can result from idiopathic, diabetic, medication-induced, or postsurgical causes. Researchers are evaluating the feasibility and effectiveness of using a gastric neurostimulation device called the Enterra system, which delivers mild electrical pulses to stimulate stomach muscles and nerves, aiming to improve symptoms and quality of life in patients with gastroparesis who do not respond to medication. The study involves patients with confirmed gastroparesis who have not improved with conservative treatments. These patients undergo laparoscopic implantation of the Enterra gastric pacemaker, a device implanted in the stomach wall to provide electrical stimulation. This observational registry trial assesses the impact of this surgical treatment over several years, focusing on symptom severity, quality of life, hospitalization frequency, perioperative complications, and cost-effectiveness. Participants will be monitored for up to five years, with evaluations of symptoms and health-related quality of life using specific questionnaires. Researchers will also track hospital admissions and possible surgical complications within one year. Assessments include gastric emptying studies to confirm diagnosis, ongoing symptom and quality of life measurement, and monitoring of safety and effectiveness of the implanted device. The total participation duration varies with long-term follow-up to observe lasting outcomes.
CONDITIONS
Brief Title
Laparoscopic Implantation of a Gastric Pacemaker in the Treatment of Gastroparesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scintigraphically proven gastroparesis
- Failed conservative therapy
- Severe impairment of quality of life
- Written informed consent
- German language
You will not qualify if you...
- Age under 18 years
- Prior gastric resection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery and immediate recovery period
Participants undergo laparoscopic implantation of a gastric pacemaker (Enterra system) to improve gastric emptying and symptoms of gastroparesis.
1 surgical visit and immediate post-operative care
Duration - Up to 1 year
Participants have follow-up visits to monitor recovery, perioperative complications, and device function after implantation.
Approximately 6 post-operative visits
Duration - 5 years
Participants are monitored for symptom severity, health-related quality of life, and hospital admissions over 5 years after device implantation.
Regular assessments during long-term follow-up visits
Trial Site Locations
Total: 1 location
1
Department of Functional Upper GI Surgery
Cologne, North Rhine-Westphalia, Germany, 51103
Actively Recruiting
Research Team
J
Jessica M Leers, Prof.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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