Escalating Temporary Gastric Electrical Stimulation (GES) for Severe Gastroparesis

Gastroparesis Clinical Trial

— TempGES  

Official title:

Escalating Temporary Gastric Electrical Stimulation for Severe Gastroparesis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02164591
• Other study ID #: Temp GES
• Status: Terminated
• Start date: February 2013
• Est. completion date: January 2019

Study information

• Verified date: August 2020
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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),

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroparesis

Locations

Country	Name	City	State
United States	Indiana University Hosptial	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in the symptoms of gastroparesis by t-GES in patients with severe gastroparesis.	Review the symptoms before and after the t-GES placements and follow for any improvement	1 month
Secondary	Clinical response to t-GES placement as measured by questionnaires	Measuring the responses to questionnaires before and after placement of GES	1 year
Secondary	Develop a prospective registry in patients undergoing escalating t-GES	Have a database of patients undergoing t-GES placement	1 year
Secondary	determine the feasibility and patient tolerability of endoscopic placement of t-GES	Determine if placement of t-GES is feasible and if the patients tolerate the t-GES	1 year