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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months
Awards & highlights
RESTING Trial 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.Check my eligibility
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.See study design
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.
RESTING Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
RESTING Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent Change in Weekly Vomiting Frequency by GCSI-DD
Scoring Change in Nausea Severity by GCSI-DD
Secondary outcome measures
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 moreRESTING 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.
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Who is running the clinical trial?
Enterra Medical, Inc.Lead Sponsor
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research program include participants of twenty-one years or older?
"Those who are of legal age (18+) and under 70 can apply to be recruited for this medical trial."
Answered by AI
What qualifications should participants possess to enter this clinical trial?
"Aspiring enrollees must meet two criteria: have gastroparesis and be between 18-70 years old. This medical trial is taking applications from 50 participants in total."
Answered by AI
How many participants are being recruited for this research trial?
"Affirmative. The information available on clinicaltrials.gov reveals that this experiment is presently gathering participants, first posted on July 10th 2023 and updated most recently on July 31st 2023. 50 people are required to be recruited from a single medical site."
Answered by AI
What is the goal of this experiment?
"The three-month trial evaluates the alteration in nausea severity by GCSI-DD. Supplementary investigations encompass the shift from baseline in GCSI-DD nausea debilitation, variance from baseline of weekly vomiting frequency as judged by GSCI-DD and mutation from initial PAGI-QoL scores."
Answered by AI
Are new participants able to join this clinical investigation?
"Affirmative. Records on clinicaltrials.gov shows that this investigation is currently enrolling participants, which first began with an announcement dated July 10th 2023 and was last updated on the 31st of July in the same year. 50 subjects are needed to be recruited from one site."
Answered by AI
Who else is applying?
What site did they apply to?
University of Louisville
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Would like to improve Gastroparesis symptoms so I can have my life back. Nothing is working.
PatientReceived no prior treatments
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