St Louis, MONCT06560307Now EnrollingIRB Ready

Gastroparesis Clinical Trial in St Louis, MO

Access cutting-edge gastroparesis treatment through this clinical trial at a research site in St Louis. Study-provided care at no cost to qualified participants.

Sponsored by Enterra Medical, Inc.

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Expert Care in St Louis

Access gastroparesis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related gastroparesis treatment provided free

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Check if you qualify for this gastroparesis clinical trial in St Louis, MO

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Why Participate?

  • No-Cost Study Care

  • Local to St Louis

    Convenient for MO residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit St Louis site if eligible
  4. 4Begin participation

About This Gastroparesis Study in St Louis

The purpose of this research study is to evaluate if an enhanced Enterra device programming strategy will improve symptoms associated with gastroparesis, improve symptoms in a faster amount of time, and improve quality of life measures. Participants in this study will be evaluated for study entry criteria, have an Enterra Therapy System implanted, and be randomly assigned to one of two programming strategies. Participants will answer daily questions about their gastroparesis symptoms on an application with their phone/tablet. Participants will answer quality of life questionnaires about their gastroparesis symptoms at monthly study visits. Participants will be involved in the study for up to six months after treatment assignment. Programming parameters in the study are within currently approved labeling.

Sponsor: Enterra Medical, Inc.

Who Can Participate

Inclusion Criteria

Completed informed consent process with signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged ≥18 or ≤70 years at time of Enterra® therapy implantation
Diagnosed with idiopathic or diabetic gastroparesis
Delayed solid-phase gastric emptying study (Eggbeaters™ test meal), completed within one year of patient enrollment in the study. Gastroparesis defined as \> 60% retained at 2 hours and/or \>10% retained at 4 hours
Investigator confirms normal endoscopy within one year of enrollment in the study
GCSI-DD score for nausea severity during the qualifying Baseline Period averaging 2.5 or more per week and vomiting averaging 5 or more episodes per week

Exclusion Criteria

Post-surgical gastroparesis (e.g., fundoplication, Billroth I or II) or other active stomach or gastrointestinal diseases disorders which could explain symptoms in the opinion of the investigator
History of pyloroplasty or pyloromyotomy or G-POEM
Pregnancy or breastfeeding at the time of consent, or intent to become pregnant during the study
Active H. pylori infection
Significant hepatic injury (elevated ALT, AST, bilirubin)
Metabolic, mechanical, or mucosal inflammatory causes that may explain GI symptoms such as gallbladder disease, small bowel bacterial overgrowth, IBS, inflammatory bowel disease, celiac disease, liver or pancreatic disease, or bowel obstruction
Patients with significant cardiac or cardiovascular disease, malignancy, or other conditions
Participation in other clinical studies
Use of narcotics more than three days per week or other drugs that may affect motility (e.g., Glucagon-like peptide 1 (GLP-1) agonist drug)
Cannabis and/or cannabinoid use that exceeds either:
Greater than 3 days of usage per week with 2 or less occurrences each day of use, or
Greater than 3 grams of total usage per week
Previous diagnosis or history of orthostatic intolerance, e.g., POTS, neurocardiogenic syncope, orthostatic hypotension
Subject experiences discomfort during stimulation assessment that cannot be tolerated
Subjects with an underlying disease leading to follow-up by MRI outside of current MR conditional indications
Evidence of a failed response to temporary gastric electrical stimulation

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in St Louis?

Yes, this clinical trial (NCT06560307) has an active research site in St Louis, MO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Gastroparesis Treatment Options in St Louis, MO

If you're searching for gastroparesis treatment options in St Louis, MO, this clinical trial (NCT06560307) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our St Louis research site is actively enrolling participants for this clinical trial. You'll receive care from experienced gastroparesis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all gastroparesis clinical trials near you to find additional studies recruiting in your area.

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