Health TrialsbyHealthPanel

Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

ConditionsGastroparesisGastroparesis NondiabeticGastroparesis Due to Diabetes Mellitus
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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Enterra® Therapy System

    Device

    The 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 3 treatment groups
Group A: Control Sleep CycleActive comparator 1 intervention
Group B: Arm 1 Sleep CycleExperimental treatment 1 intervention
Group C: Arm 2 Sleep CycleExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change in Weekly Vomiting Frequency by GCSI-DD

Less than a 50% increase in GCSI-DD weekly vomiting frequency from baseline

Time frame
3 Months, 6 Months
2

Scoring Change in Nausea Severity by GCSI-DD

Less than a 1-point increase in GCSI-DD nausea severity from baseline

Time frame
3 Months, 6 Months

Secondary outcomes

1

Mean Change from Baseline in GCSI-DD Total Symptom Score

Change in GCSI-DD Total Symptom Score from baseline

Time frame
3 Months, 6 Months
2

Mean Change from Baseline in GCSI-DD Nausea Severity

Change in GCSI-DD nausea severity from baseline

Time frame
3 Months, 6 Months
3

Mean Change from Baseline in GCSI-DD Weekly Vomiting Frequency

Change in GCSI-DD weekly vomiting frequency from baseline

Time frame
3 Months, 6 Months
4

Mean Change from Baseline in PAGI-QoL Scores

Change in PAGI-QoL from baseline

Time frame
3 Months, 6 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Enterra Medical, Inc.

Lead sponsor

Source ClinicalTrials.gov
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