Escalating Temporary Gastric Electrical Stimulation (GES) for Severe Gastroparesis (TempGES)

August 1, 2020 updated by: John M. Wo, Indiana University

Escalating Temporary Gastric Electrical Stimulation for Severe Gastroparesis

The purpose of this study is to determine the physiologic effects of temporary gastric electrical stimulation in subjects with severe gastroparesis.

Study Overview

Status

Terminated

Conditions

Detailed Description

This study will look to determine the clinical benefit placing temporary gastric electrical stimulation, the ability to predict the clinical response to surgical implantation of GES, and the feasibility and patient tolerability of endoscopic placement of temporary Gastric Electrical Stimulator (t-GES),

Study Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Hosptial

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who have been diagnosed with gatroparesis.

Description

Inclusion Criteria:

  • At least 3 months of gastroparesis-related symptoms, such as nausea, emesis, and/or retching

  • Solid phase 4-hr gastric scintigraphy is consistent with gastroparesis within 3 months of study enrollment*

    • retention at 2 hr: >60% or
    • retention at 4 hr: >10% *Based on International consensus on gastric scintigraphy

Exclusion Criteria:

  • Gastric outlet, small bowel, or colon obstruction.
  • Small bowel malrotation
  • Inflammatory bowel disease
  • Contraindication for surgical implantation of GES
  • Presence of illness that may require MRI during the study; such as pituitary tumor, herniated disc, spinal stenosis, multiple sclerosis, etc.
  • Significant comorbidity due to sever cardiovascular, renal, pulmonary, or liver disease.
  • Significant coagulopathy
  • Non-ambulatory patients: bed-ridden, nursing home resident, etc.
  • Pregnancy
  • Unable to give own informed consent
  • Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in the symptoms of gastroparesis by t-GES in patients with severe gastroparesis.
Time Frame: 1 month
Review the symptoms before and after the t-GES placements and follow for any improvement
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response to t-GES placement as measured by questionnaires
Time Frame: 1 year
Measuring the responses to questionnaires before and after placement of GES
1 year
Develop a prospective registry in patients undergoing escalating t-GES
Time Frame: 1 year
Have a database of patients undergoing t-GES placement
1 year
determine the feasibility and patient tolerability of endoscopic placement of t-GES
Time Frame: 1 year
Determine if placement of t-GES is feasible and if the patients tolerate the t-GES
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: John M Wo, MD, Indiana University

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 Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

June 6, 2014

First Submitted That Met QC Criteria

June 13, 2014

First Posted (Estimate)

June 16, 2014

Study Record Updates

Last Update Posted (Actual)

August 4, 2020

Last Update Submitted That Met QC Criteria

August 1, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Temp GES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastroparesis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe