Gastroparesis Trial, Recruiting NCT05980455 Sponsor: Enterra Medical, Inc. Condition: Gastroparesis
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Gastroparesis Trial, Recruiting

NCT05980455
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 a man or woman aged 18 to 70 years old at the time of signing the consent form
  • You currently have an Enterra® II gastric electrical stimulator (a specific stomach nerve stimulation device) implanted
  • Your implanted device is expected to have more than 9 months of battery life remaining, and it was implanted less than 4 years ago
  • Your gastroparesis (stomach emptying condition) symptoms are considered stable by the study doctor
  • You are on a stable medication routine for your gastroparesis symptoms
  • Your nutritional support (such as supplements or feeding support) has not changed in the month before joining the study
  • You can read and understand English well enough to complete the study questionnaires and assessments
  • You have reliable access to a smartphone, tablet, or other internet-connected device to complete study tasks

Who may not be able to join:

  • Your gastroparesis was caused by a previous stomach surgery (such as fundoplication or certain ulcer surgeries), or you have another active stomach or gut condition that could explain your symptoms (confirm with trial site)
  • You experience severe nausea and/or vomiting at night, in the opinion of the study doctor
  • You experience severe gastroparesis symptoms when you wake up in the morning, in the opinion of the study doctor
  • You do not have a regular, consistent sleep schedule
  • You are currently pregnant or plan to become pregnant during the study
  • You have a dependency on alcohol or drugs
  • A technical measurement of your Enterra device's electrical leads shows a reading of 700 Ohms or higher at your screening visit (confirm with trial site)
  • You have a health condition (unrelated to your digestive system) that means you are not expected to live longer than 1 year
  • You have a condition that requires you to have MRI scans in a way that is not compatible with your implanted device (confirm with trial site)
  • You are currently taking part in another clinical trial
  • You are involved in any current or past legal action related to a medical matter
  • You have a cognitive impairment or other condition that would make it difficult to complete the study requirements

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: Abigail Stocker, MD, University of Louisville

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
10 July 2023
Est. completion
1 August 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Percent Change in Weekly Vomiting Frequency by GCSI-DD; Scoring Change in Nausea Severity by GCSI-DD

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