RECRUITING

Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Randomized Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

Quick Facts

Study Start:2023-07-10
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05980455

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Timothy McAllister
CONTACT
855-768-3772
clinicalresearch@enterramedical.com
Jason Hamann, PhD
CONTACT
855-768-3772
clinicalresearch@enterramedical.com

Principal Investigator

Abigail Stocker, MD
PRINCIPAL_INVESTIGATOR
University of Louisville

Study Locations (Sites)

University of Louisville
Louisville, Kentucky, 40202
United States
MNGI Digestive Health, P.A.
Coon Rapids, Minnesota, 55433
United States

Collaborators and Investigators

Sponsor: Enterra Medical, Inc.

  • Abigail Stocker, MD, PRINCIPAL_INVESTIGATOR, University of Louisville

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-10
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-07-10
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Gastric electrical stimulation
  • Gastroparesis

Additional Relevant MeSH Terms

  • Gastroparesis
  • Gastroparesis Nondiabetic
  • Gastroparesis Due to Diabetes Mellitus