Implanting a gastric pacemaker to treat gastroparesis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Enhanced programming stimulation for gastroparesis treatment

  This study is testing if a new way of programming a device for treating gastroparesis can help people feel better and improve their quality of life faster.

  Recruiting at 6 sites Enterra Medical, Inc. · Tampa, Florida and 5 other locations · NCT06560307

• Evaluating Enterra Device Programming for Gastroparesis Relief During Sleep

  This study is testing different ways to program the Enterra® device at night to see if it helps people with gastroparesis feel better while they sleep.

  Recruiting at 2 sites Enterra Medical, Inc. · Louisville, Kentucky and 1 other locations · NCT05980455

• Registry for patients with gastroparesis and functional dyspepsia

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  Recruiting at 6 sites Johns Hopkins Bloomberg School of Public Health · Scottsdale, Arizona and 5 other locations · NCT05846802

• Gastric-focused ultrasound to see if it changes stomach activity and symptoms

  This study tests whether noninvasive stomach-focused ultrasound can alter post-meal stomach electrical activity and symptoms in adults with gastroparesis or delayed gastric emptying, using a sham control in a crossover design.

  Recruiting University of Texas at Austin · Austin, Texas · NCT07851727

• Gastric emptying and feeding tolerance in ICU patients by vasopressor dose

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  Recruiting Başakşehir Çam & Sakura City Hospital · Istanbul · NCT07802379

• Virtual poetry workshops to boost well-being for people with digestive symptoms

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  Recruiting Ohio State University · Columbus, Ohio · NCT07717541

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.