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GastroparesisRESTINGNCT05980455

Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

A study testing Enterra® Therapy System in people with Gastroparesis and Gastroparesis Nondiabetic, run by Enterra Medical, Inc. at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Enterra® Therapy System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesUnited States
Study dates
10 Jul 2023to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Timothy McAllister contact

855-768-3772

clinicalresearch@enterramedical.com

Jason Hamann, PhD contact

855-768-3772

clinicalresearch@enterramedical.com

United States2 sites, 2 recruiting

  • MNGI Digestive Health, P.A.

    Coon Rapids, Minnesota, 55433

    Roxanne Strehlo

    April Grudell, MD

    Recruiting

  • University of Louisville

    Louisville, Kentucky, 40202

    Abigail Stocker, MD, 5025884600, abigail.stocker@louisville.edu

    Abigail Stocker, MD

    Recruiting

Other trials in United States

About this study

Official title: Randomized Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

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.

Read more

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.

Being tested
Enterra® Therapy System
Keywords
Gastric electrical stimulation, Gastroparesis
Medical subject headings
Gastroparesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enterra® Therapy SystemDevice

    Also called Gastric electrical stimulation

    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.

Study groups in NCT05980455
Study groupRoleWhat they receive
Control Sleep CycleActive comparatorBaseline device programming parameters will be used during study participation. No modification to Enterra® device programming will be in effect during waking or sleeping hours.
Receives: Device: Enterra® Therapy System
Arm 1 Sleep CycleExperimentalDevice 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.
Receives: Device: Enterra® Therapy System
Arm 2 Sleep CycleExperimentalDevice 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.
Receives: Device: Enterra® Therapy System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change in Weekly Vomiting Frequency by GCSI-DD

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

    Measured: 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

    Measured: 3 Months, 6 Months

Secondary outcomes (5)

  1. Mean Change from Baseline in GCSI-DD Total Symptom Score

    Change in GCSI-DD Total Symptom Score from baseline

    Measured: 3 Months, 6 Months

  2. Mean Change from Baseline in GCSI-DD Nausea Severity

    Change in GCSI-DD nausea severity from baseline

    Measured: 3 Months, 6 Months

  3. Mean Change from Baseline in GCSI-DD Weekly Vomiting Frequency

    Change in GCSI-DD weekly vomiting frequency from baseline

    Measured: 3 Months, 6 Months

  4. Mean Change from Baseline in PAGI-QoL Scores

    Change in PAGI-QoL from baseline

    Measured: 3 Months, 6 Months

  5. Mean Change from Baseline in Quality of Sleep Scores

    Change in Quality of Sleep from baseline

    Measured: 3 Months, 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2023
  2. Study start10 Jul 2023
  3. Primary completionAug 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05980455
Sponsor's protocol ID
CLN 001-PR-00755
Acronym
RESTING
Status last verified
Nov 2024
First submitted
31 Jul 2023
Last updated
15 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Enterra® Therapy System in people with Gastroparesis and Gastroparesis Nondiabetic, run by Enterra Medical, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Timothy McAllister (855-768-3772, clinicalresearch@enterramedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Weekly Vomiting Frequency by GCSI-DD (time frame: 3 Months, 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05980455.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.

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