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NCT06661668
Laparoscopic Implantation of a Gastric Pacemaker in the Treatment of Gastroparesis
trial testing Gastric pacemaker (Enterra system) implantation in Gastroparesis in 50 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | Evangelic Hospital Kalk Cologne |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 1 January 2023 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Gastric pacemaker (Enterra system) implantation
Conditions studied
- Gastroparesis — all drugs for Gastroparesis →
- Gastroparesis Postoperative — all drugs for Gastroparesis Postoperative →
- Gastroparesis Nondiabetic — all drugs for Gastroparesis Nondiabetic →
- Gastroparesis With Diabetes Mellitus — all drugs for Gastroparesis With Diabetes Mellitus →
Sponsor
Evangelic Hospital Kalk Cologne
Who can join
18 and older, any sex, with Gastroparesis or Gastroparesis Postoperative. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06661668
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for Gastroparesis
Currently open trials in the same condition.
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- NCT07104214 — Development and Validation of a Risk Prediction Model for Gastric Retention in Patients Undergoing Sedated Gastroscopy · recruiting
- NCT07526935 — Combined Role of Gastric Peroral Endoscopic Myotomy and Gastric Electrical Stimulator · NA · active not recruiting
- NCT05981300 — GpCRC Pediatric Gastroparesis Registry 2 · recruiting
- NCT06580197 — The Role of AAT After Abdominal Surgery Based on RWS · recruiting
Other Evangelic Hospital Kalk Cologne trials
Trials by the same sponsor.
- NCT06597578 — Prospective Köln Bonn Registry for the Extraction of Pacmaker and ICD Leads · recruiting
- NCT06151067 — Important Correlation Between Anxiety and Reflux Symptoms in Patients With Gastroesophageal Reflux Disease · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06661668 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Evangelic Hospital Kalk Cologne
- Last refreshed: 12 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06661668.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing