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Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

Randomized Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05980455
Acronym
RESTING
Enrollment
50
Registered
2023-08-08
Start date
2023-07-10
Completion date
2025-12-31
Last updated
2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroparesis, Gastroparesis Due to Diabetes Mellitus, Gastroparesis Nondiabetic

Keywords

Gastric electrical stimulation, Gastroparesis

Brief summary

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.

Interventions

DEVICEEnterra® Therapy System

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.

Sponsors

Enterra Medical, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

In order to be eligible to participate in this study, a participant must meet all of the following 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 at time of informed consent; 4. Currently implanted with the Enterra® Therapy System (Enterra® II 37800 neurostimulator); 5. 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; 6. Stable gastroparesis symptoms, in the opinion of the investigator; 7. On stable medical therapy for gastroparesis symptoms; 8. On stable supplemental nutritional support during the month prior to enrollment; 9. English language comprehension to complete study-required assessments; 10. 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: 1. 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; 2. Subjects, in the opinion of the investigator, with profound nausea and/or vomiting at night; 3. Subjects, in the opinion of the investigator, with profound gastroparesis symptoms upon waking in the morning; 4. Subjects without a regular and defined sleep schedule; 5. Pregnancy, or subject that intends to become pregnant during participation in the study; 6. Chemical dependency; 7. Enterra lead impedance measurements ≥ 700 Ohms at screening visit; 8. Life expectancy \< 1 year from conditions other than GI diseases; 9. Subjects with an underlying disease leading to follow-up by MRI outside of current MR conditional indications; 10. Participation in other clinical studies; 11. Subjects involved in current or past medical-related litigation; 12. Subjects with cognitive impairment or other characteristic that would limit subject's ability to complete study requirements.

Design outcomes

Primary

MeasureTime frameDescription
Percent Change in Weekly Vomiting Frequency by GCSI-DD3 Months, 6 MonthsLess than a 50% increase in GCSI-DD weekly vomiting frequency from baseline
Scoring Change in Nausea Severity by GCSI-DD3 Months, 6 MonthsLess than a 1-point increase in GCSI-DD nausea severity from baseline

Secondary

MeasureTime frameDescription
Mean Change from Baseline in GCSI-DD Weekly Vomiting Frequency3 Months, 6 MonthsChange in GCSI-DD weekly vomiting frequency from baseline
Mean Change from Baseline in GCSI-DD Total Symptom Score3 Months, 6 MonthsChange in GCSI-DD Total Symptom Score from baseline
Mean Change from Baseline in Quality of Sleep Scores3 Months, 6 MonthsChange in Quality of Sleep from baseline
Mean Change from Baseline in PAGI-QoL Scores3 Months, 6 MonthsChange in PAGI-QoL from baseline
Mean Change from Baseline in GCSI-DD Nausea Severity3 Months, 6 MonthsChange in GCSI-DD nausea severity from baseline

Countries

United States

Contacts

Primary ContactTimothy McAllister
clinicalresearch@enterramedical.com855-768-3772
Backup ContactJason Hamann, PhD
clinicalresearch@enterramedical.com855-768-3772

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026