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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
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 belowSelect...
I am between 18 and 70 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
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
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 moreTrial 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.
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Who is running the clinical trial?
Enterra Medical, Inc.Lead Sponsor
2 Previous Clinical Trials
198 Total Patients Enrolled
1 Trials studying Gastroparesis
50 Patients Enrolled for Gastroparesis
Abigail Stocker, MDPrincipal InvestigatorUniversity of Louisville
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I often feel very nauseous or vomit at night.I experience severe stomach emptying issues when I wake up.I am willing and able to follow all study rules and attend all appointments.I have been told I have less than a year to live due to conditions not related to my digestive system.My gastroparesis symptoms are managed with consistent medication.I am between 18 and 70 years old.I am being monitored with MRI scans due to my condition.The measurement of the Enterra lead's impedance is greater than or equal to 700 Ohms during the screening visit.I am able to understand and follow the study's requirements.You currently have a neurostimulator called the Enterra™ Therapy System implanted in your body.I have had stomach surgery or have an active stomach disease that could explain my symptoms.You are currently involved in a lawsuit related to medical issues, or have been involved in the past.Your implanted device is expected to last between 9 months and 4 years from the time of enrollment.You do not have a regular sleep schedule.You have a problem with using drugs or alcohol.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2 Sleep Cycle
- Group 2: Control Sleep Cycle
- Group 3: Arm 1 Sleep Cycle
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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