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Study of Enterra Programming With Nocturnal Cycling in Gastroparetics (RESTING)

Primary Purpose

Gastroparesis, Gastroparesis Nondiabetic, Gastroparesis Due to Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enterra™ Therapy System
Sponsored by
Enterra Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroparesis focused on measuring Gastric electrical stimulation, Gastroparesis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

In order to be eligible to participate in this study, a participant must meet all of the following criteria: Completed informed consent process with signed and dated informed consent form; Stated willingness to comply with all study procedures and availability for the duration of the study; Male or female, aged ≥18 or ≤70 at time of informed consent; Currently implanted with the Enterra™ Therapy System (Enterra™ II 37800 neurostimulator); 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; Stable gastroparesis symptoms, in the opinion of the investigator; On stable medical therapy for gastroparesis symptoms; On stable supplemental nutritional support during the month prior to enrollment. A participant who meets any of the following criteria will be excluded from participation in this study: 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; Subjects, in the opinion of the investigator, with profound nausea and/or vomiting at night; Subjects, in the opinion of the investigator, with profound gastroparesis symptoms upon waking in the morning; Subjects without a regular and defined sleep schedule; Pregnancy, or subject that intends to become pregnant during participation in the study; Chemical dependency; Enterra lead impedance measurements ≥ 700 Ohms at screening visit; Life expectancy < 1 year from conditions other than GI diseases; Subjects with an underlying disease leading to follow-up by MRI; Participation in other clinical studies; Subjects involved in current or past medical-related litigation; Subjects with cognitive impairment or other characteristic that would limit subject's ability to complete study requirements.

Sites / Locations

  • University of LouisvilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control Sleep Cycle

Arm 1 Sleep Cycle

Arm 2 Sleep Cycle

Arm Description

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 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 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.

Outcomes

Primary Outcome Measures

Percent Change in Weekly Vomiting Frequency by GCSI-DD
Less than a 50% increase in GCSI-DD weekly vomiting frequency from baseline
Scoring Change in Nausea Severity by GCSI-DD
Less than a 1-point increase in GCSI-DD nausea severity from baseline

Secondary Outcome Measures

Mean Change from Baseline in GCSI-DD Total Symptom Score
Change in GCSI-DD Total Symptom Score from baseline
Mean Change from Baseline in GCSI-DD Nausea Severity
Change in GCSI-DD nausea severity from baseline
Mean Change from Baseline in GCSI-DD Weekly Vomiting Frequency
Change in GCSI-DD weekly vomiting frequency from baseline
Mean Change from Baseline in PAGI-QoL Scores
Change in PAGI-QoL from baseline
Mean Change from Baseline in Quality of Sleep Scores
Change in Quality of Sleep from baseline

Full Information

First Posted
July 31, 2023
Last Updated
July 31, 2023
Sponsor
Enterra Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05980455
Brief Title
Study of Enterra Programming With Nocturnal Cycling in Gastroparetics
Acronym
RESTING
Official Title
Randomized Study of Enterra Programming With Nocturnal Cycling in Gastroparetics
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enterra Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis, Gastroparesis Nondiabetic, Gastroparesis Due to Diabetes Mellitus
Keywords
Gastric electrical stimulation, Gastroparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Sleep Cycle
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arm 1 Sleep Cycle
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 2 Sleep Cycle
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Enterra™ Therapy System
Other Intervention Name(s)
Gastric electrical stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Change in Weekly Vomiting Frequency by GCSI-DD
Description
Less than a 50% increase in GCSI-DD weekly vomiting frequency from baseline
Time Frame
3 Months, 6 Months
Title
Scoring Change in Nausea Severity by GCSI-DD
Description
Less than a 1-point increase in GCSI-DD nausea severity from baseline
Time Frame
3 Months, 6 Months
Secondary Outcome Measure Information:
Title
Mean Change from Baseline in GCSI-DD Total Symptom Score
Description
Change in GCSI-DD Total Symptom Score from baseline
Time Frame
3 Months, 6 Months
Title
Mean Change from Baseline in GCSI-DD Nausea Severity
Description
Change in GCSI-DD nausea severity from baseline
Time Frame
3 Months, 6 Months
Title
Mean Change from Baseline in GCSI-DD Weekly Vomiting Frequency
Description
Change in GCSI-DD weekly vomiting frequency from baseline
Time Frame
3 Months, 6 Months
Title
Mean Change from Baseline in PAGI-QoL Scores
Description
Change in PAGI-QoL from baseline
Time Frame
3 Months, 6 Months
Title
Mean Change from Baseline in Quality of Sleep Scores
Description
Change in Quality of Sleep from baseline
Time Frame
3 Months, 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
In order to be eligible to participate in this study, a participant must meet all of the following criteria: Completed informed consent process with signed and dated informed consent form; Stated willingness to comply with all study procedures and availability for the duration of the study; Male or female, aged ≥18 or ≤70 at time of informed consent; Currently implanted with the Enterra™ Therapy System (Enterra™ II 37800 neurostimulator); 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; Stable gastroparesis symptoms, in the opinion of the investigator; On stable medical therapy for gastroparesis symptoms; On stable supplemental nutritional support during the month prior to enrollment. A participant who meets any of the following criteria will be excluded from participation in this study: 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; Subjects, in the opinion of the investigator, with profound nausea and/or vomiting at night; Subjects, in the opinion of the investigator, with profound gastroparesis symptoms upon waking in the morning; Subjects without a regular and defined sleep schedule; Pregnancy, or subject that intends to become pregnant during participation in the study; Chemical dependency; Enterra lead impedance measurements ≥ 700 Ohms at screening visit; Life expectancy < 1 year from conditions other than GI diseases; Subjects with an underlying disease leading to follow-up by MRI; Participation in other clinical studies; Subjects involved in current or past medical-related litigation; Subjects with cognitive impairment or other characteristic that would limit subject's ability to complete study requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy McAllister
Phone
855-768-3772
Email
clinicalresearch@enterramedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Hamann, PhD
Phone
855-768-3772
Email
clinicalresearch@enterramedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abigail Stocker, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abigail Stocker, MD
Phone
502-588-4600
Email
abigail.stocker@louisville.edu
First Name & Middle Initial & Last Name & Degree
Abigail Stocker, MD

12. IPD Sharing Statement

Learn more about this trial

Study of Enterra Programming With Nocturnal Cycling in Gastroparetics

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