Study of Enhanced Programming Stimulation with the Enterra® Therapy System

Part of paid clinical trials in Tampa, Florida.

Sponsor
Enterra Medical, Inc.
Study ID
NCT06560307
Status
Recruiting
Apply to this trial

Conditions

  • Gastroparesis
  • Gastroparesis Due to Diabetes Mellitus
  • Gastroparesis Nondiabetic

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

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.

Study Details

The purpose of this research study is to evaluate if an enhanced Enterra device programming strategy will improve symptoms associated with gastroparesis, improve symptoms in a faster amount of time, and improve quality of life measures. Participants in this study will be evaluated for study entry criteria, have an Enterra Therapy System implanted, and be randomly assigned to one of two programming strategies. 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 monthly 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.

Key Dates

Start date
Jul 25, 2024
Status verified
Nov 2024
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control Programming Stimulation
    Begin with nominal (lower stimulation) programming settings at Enterra Therapy System implantation. At treatment assignment, nominal programming will continue. Slight increases in device amplitude (stimulation) will be done at 3 Month visit and at later follow-up visits.
  • Experimental: Enhanced Programming Stimulation
    Begin with nominal (lower stimulation) programming settings at Enterra Therapy System implantation. At treatment assignment, moderate increases in device amplitude (stimulation) and duty cycle (on/off cycles) will be done. Further adjustments to amplitude, duty cycle, and/or frequency (rate of pulses) will be done at follow-up visits.

Primary Outcome Measure

Change in Vomiting Absolute Frequency [ Time Frame: 3 Months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of South FloridaTampaFlorida33620
Beth Montera
[email protected]
(813)844-7948
Joseph Sujka, MD
University of LouisvilleLouisvilleKentucky40202
Amy Perdue
Abigail Stocker, MD
Henry Ford Health SystemDetroitMichigan48202
Daniel Molitor
[email protected]
(313)-916-8194
Kellie McFarlin, MD
Washington UniversitySt LouisMissouri63110
Asima Badic
Michael Awad, MD, PhD
Foundation for Surgical InnovationPortlandOregon97213
Angi Gill
Christy Dunst, MD
Benaroya Research Institute at Virginia MasonSeattleWashington98101
Cheryl Shaw
Pierre Blais, MD

Find similar trials in Tampa, FL

By research site
University of South Florida· Tampa, FLUniversity of Louisville· Louisville, KYHenry Ford Health System· Detroit, MIWashington University· St Louis, MOFoundation for Surgical Innovation· Portland, ORBenaroya Research Institute at Virginia Mason· Seattle, WA

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