Study of Enhanced Programming Stimulation with the Enterra® Therapy System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEnterra Medical, Inc.
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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Enterra Therapy System
DeviceThe Enterra® Therapy System for gastric electrical stimulation (GES) is indicated for the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Control Programming StimulationActive comparator 1 intervention
Group B: Enhanced Programming StimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Vomiting Absolute Frequency
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) weekly vomiting absolute frequency
Time frame
3 Months2
Change in Nausea Severity Score
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) nausea severity score
Time frame
3 MonthsSecondary outcomes
1
Change in Vomiting Absolute Frequency
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) weekly vomiting absolute frequency
Time frame
6 Months2
Change in Nausea Severity Score
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) nausea severity score
Time frame
6 Months3
Change in Total Symptom Score
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) total symptom score
Time frame
3 Months4
Change in Total Symptom Score
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) total symptom score
Time frame
6 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov