Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

NCT05980455 | Recruiting FDA Device

• 1 other identifier: CLN 001-PR-00755
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Gastroparesis; Gastroparesis Nondiabetic; Gastroparesis Due to Diabetes Mellitus

Keywords

Gastric electrical stimulation; Gastroparesis

Outcome Measures

Primary Outcomes (2)

• Percent Change in Weekly Vomiting Frequency by GCSI-DD

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

  3 Months, 6 Months

• Scoring Change in Nausea Severity by GCSI-DD

  Less than a 1-point increase in GCSI-DD nausea severity from baseline

  3 Months, 6 Months

Secondary Outcomes (5)

• Mean Change from Baseline in GCSI-DD Total Symptom Score

  3 Months, 6 Months

• Mean Change from Baseline in GCSI-DD Nausea Severity

  3 Months, 6 Months

• Mean Change from Baseline in GCSI-DD Weekly Vomiting Frequency

  3 Months, 6 Months

• Mean Change from Baseline in PAGI-QoL Scores

  3 Months, 6 Months

• Mean Change from Baseline in Quality of Sleep Scores

  3 Months, 6 Months

Study Arms (3)

Control Sleep Cycle

ACTIVE COMPARATOR

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.

Device: Enterra® Therapy System

Arm 1 Sleep Cycle

EXPERIMENTAL

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.

Device: Enterra® Therapy System

Arm 2 Sleep Cycle

EXPERIMENTAL

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.

Device: Enterra® Therapy System

Interventions

Enterra® Therapy System DEVICE

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.

Also known as: Gastric electrical stimulation

Arm 1 Sleep Cycle; Arm 2 Sleep Cycle; Control Sleep Cycle

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Enterra Medical, Inc.: lead

Study Sites (2)

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

MNGI Digestive Health, P.A.

Coon Rapids, Minnesota, 55433, United States

RECRUITING

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Abigail Stocker, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy McAllister

CONTACT

855-768-3772; clinicalresearch@enterramedical.com

Jason Hamann, PhD

CONTACT

855-768-3772; clinicalresearch@enterramedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 8, 2023
• Study Start: July 10, 2023
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)