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Procedure

Enterra Programming for Gastroparesis (RESTING Trial)

N/A

Recruiting

Led By Abigail Stocker, MD

Research Sponsored by Enterra Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female, aged ≥18 or ≤70 at time of informed consent

Be older than 18 years old

Must not have

Life expectancy < 1 year from conditions other than GI diseases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate if different Enterra™ device programming methods during sleep can help people with gastroparesis-related symptoms and quality of life. Participants use app on phone/tablet, answer questionnaires and be involved for up to 6 months.

Who is the study for?

This trial is for adults aged 18-70 with gastroparesis who already have the Enterra™ Therapy System implanted and are on stable medical therapy. They should not have cognitive impairments, other GI diseases that explain symptoms, severe night-time nausea/vomiting, or an irregular sleep schedule. Pregnant individuals or those planning pregnancy during the study are excluded.

What is being tested?

The study tests if different programming methods of the Enterra™ device during sleep can help maintain symptom relief and quality of life in people with gastroparesis. Participants will be randomly assigned to one of three programming methods and monitored for up to six months.

What are the potential side effects?

While specific side effects aren't listed here, participants may experience issues related to changes in their device's programming which could affect their gastroparesis symptoms or overall comfort at night.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been told I have less than a year to live due to conditions not related to my digestive system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent Change in Weekly Vomiting Frequency by GCSI-DD

Scoring Change in Nausea Severity by GCSI-DD

Secondary study objectives

Mean Change from Baseline in GCSI-DD Nausea Severity

Mean Change from Baseline in GCSI-DD Total Symptom Score

Mean Change from Baseline in GCSI-DD Weekly Vomiting Frequency

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2 Sleep CycleExperimental Treatment1 Intervention

Device programming parameters participants have at enrollment will be used during waking hours. During sleeping hours, the Enterra® device will cycle through modified programming over the course of 8 hours. Each hour, the Enterra® device will deliver 45 minutes of reduced stimulation, followed by 15 minutes of waking hours stimulation. At the end of the 8-hour sleep cycle, the Enterra® device will return to waking hours programming.

Group II: Arm 1 Sleep CycleExperimental Treatment1 Intervention

Device programming parameters participants have at enrollment will be used during waking hours. During sleeping hours, the Enterra® device will cycle through modified programming over the course of 6 hours. Each hour, the Enterra® device will deliver 30 minutes of reduced stimulation, followed by 30 minutes of waking hours stimulation. At the end of the 6-hour sleep cycle, the Enterra® device will return to waking hours programming.

Group III: Control Sleep CycleActive Control1 Intervention

Baseline device programming parameters will be used during study participation. No modification to Enterra® device programming will be in effect during waking or sleeping hours.

0 / 2Eligibility criteria met