Coon Rapids, MNNCT05980455Now EnrollingIRB Ready

Gastroparesis Clinical Trial in Coon Rapids, MN

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

Sponsored by Enterra Medical, Inc.

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Expert Care in Coon Rapids

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 Coon Rapids, MN

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Why Participate?

  • No-Cost Study Care

  • Local to Coon Rapids

    Convenient for MN 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 Coon Rapids site if eligible
  4. 4Begin participation

About This Gastroparesis Study in Coon Rapids

The purpose of this research study is to evaluate if different Enterra® device programming methods active during sleeping hours can maintain gastroparesis-related symptom relief and quality of life measures. Participants in this study with existing Enterra® devices will be randomly assigned to one of three programming methods that will be active during sleep. 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 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

In order to be eligible to participate in this study, a participant must meet all of the following 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 at time of informed consent;
Currently implanted with the Enterra® Therapy System (Enterra® II 37800 neurostimulator);
High GES output defined as remaining pulse generator expected life of \> 9 months from enrollment and less than 4 years from the time of implant;
Stable gastroparesis symptoms, in the opinion of the investigator;
On stable medical therapy for gastroparesis symptoms;
On stable supplemental nutritional support during the month prior to enrollment;
English language comprehension to complete study-required assessments;
Reliable access to internet-connected smart device(s) to complete study-required assessments. A participant who meets any of the following criteria will be excluded from participation in this study:
Post-surgical gastroparesis (e.g., fundoplication, Bilroth I or II) or other active stomach or gastrointestinal diseases disorders which could explain symptoms in the opinion of the investigator;
Subjects, in the opinion of the investigator, with profound nausea and/or vomiting at night;
Subjects, in the opinion of the investigator, with profound gastroparesis symptoms upon waking in the morning;
Subjects without a regular and defined sleep schedule;
Pregnancy, or subject that intends to become pregnant during participation in the study;
Chemical dependency;
Enterra lead impedance measurements ≥ 700 Ohms at screening visit;
Life expectancy \< 1 year from conditions other than GI diseases;
Subjects with an underlying disease leading to follow-up by MRI outside of current MR conditional indications;
Participation in other clinical studies;
Subjects involved in current or past medical-related litigation;
Subjects with cognitive impairment or other characteristic that would limit subject's ability to complete study requirements.

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 Coon Rapids?

Yes, this clinical trial (NCT05980455) has an active research site in Coon Rapids, MN 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 Coon Rapids, MN

If you're searching for gastroparesis treatment options in Coon Rapids, MN, this clinical trial (NCT05980455) 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 Coon Rapids 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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