Gastroparesis Trial, Recruiting NCT06560307 Sponsor: Enterra Medical, Inc. Condition: Gastroparesis
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Gastroparesis Trial, Recruiting

NCT06560307
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are willing to sign a consent form and agree to follow all study requirements for the full duration of the trial
  • You are between 18 and 70 years old at the time of receiving the Enterra® stomach stimulation device
  • You have been diagnosed with gastroparesis (delayed stomach emptying) caused by either an unknown reason or by diabetes
  • You have had a stomach-emptying test using a specific egg-based meal within the last year, showing that your stomach empties food unusually slowly
  • A doctor has confirmed your stomach lining looked normal on a camera test (endoscopy) within the last year
  • Your symptoms of nausea are rated at a certain level of severity on average each week, and you are vomiting 5 or more times per week, based on a specific symptom scoring tool

Who may not be able to join:

  • Your gastroparesis was caused by a previous stomach surgery (such as certain types of stomach or anti-reflux operations)
  • You have had a previous procedure to widen or cut open the valve between your stomach and small intestine (confirm with trial site)
  • You are currently pregnant, breastfeeding, or planning to become pregnant during the study
  • You have an active H. pylori stomach infection
  • You have significant liver damage, shown by abnormal liver blood test results
  • Your stomach symptoms may be explained by another condition, such as gallbladder disease, irritable bowel syndrome, inflammatory bowel disease, celiac disease, liver or pancreatic disease, bowel blockage, or bacterial overgrowth in the small intestine
  • You have serious heart or cardiovascular disease, cancer, or certain other significant health conditions (confirm with trial site)
  • You are currently taking part in another clinical trial
  • You use narcotic pain medications more than three days per week, or take certain other medications that affect how your gut moves, such as GLP-1 drugs (a type of diabetes or weight-loss medication)
  • You use cannabis or cannabinoid products more than three days per week, or use more than 3 grams in total per week, or use it more than twice per day of use
  • You have a history of a condition causing dizziness or fainting when standing up, such as POTS or low blood pressure when standing
  • You found the stimulation test during the assessment process too uncomfortable to tolerate
  • You have a medical condition that requires you to have MRI scans in a way that may not be compatible with the implanted device (confirm with trial site)
  • A temporary version of the stomach stimulation device was previously tried and did not help your symptoms

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Michael Awad, MD, PhD, Washington University School of Medicine

Phone: 855-768-3772

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Enterra Medical, Inc.
Registry
ClinicalTrials.gov
Start date
25 July 2024
Est. completion
1 October 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Vomiting Absolute Frequency; Change in Nausea Severity Score

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov