Enhanced Enterra Therapy for Gastroparesis

Study of Enhanced Programming Stimulation with the Enterra® Therapy System

Recruiting N/A Interventional Study
Gastroparesis Gastroparesis Nondiabetic Gastroparesis Due to Diabetes Mellitus
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 70
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Enterra Medical, Inc. · Industry
Who this trial is looking for

This trial is looking for adults with gastroparesis who want to see if a new way of programming the Enterra device can help improve their symptoms faster and better. Participants will have the Enterra device implanted and will track their symptoms for six months using an app.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 18 and 70 years old.
  • I have been diagnosed with idiopathic or diabetic gastroparesis.
  • I have completed a gastric emptying study showing delayed stomach emptying.
  • I have a recent normal endoscopy.
  • I experience nausea severity averaging 2.5 or more per week.
  • I experience vomiting averaging 5 or more episodes per week.
  • I understand and agree to follow all study procedures.
  • I have signed the informed consent form.

You may not be able to join if

  • I have post-surgical gastroparesis or other gastrointestinal diseases.
  • I am pregnant or breastfeeding.
  • I have an active H. pylori infection.
  • I have significant liver injury.
  • I have serious heart disease or cancer.
  • I am participating in another clinical study.
  • I use narcotics more than three days a week.
  • I have a history of orthostatic intolerance.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About This Trial
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 programmin…
Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: 1. Completed informed consent process with signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged ≥18 or ≤70 years at time of Enterra® therapy implantation 4. Diagnos…
Contacts

Timothy McAllister

855-768-3772

clinicalresearch@enterramedical.com

CONTACT

Jason Hamann, PhD

855-768-3772

clinicalresearch@enterramedical.com

CONTACT