Escalating Temporary Gastric Electrical Stimulation (GES) for Severe Gastroparesis

NCT02164591 | Terminated DMC

• 1 other identifier: Temp GES
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastroparesis

Keywords

gastroparesis; gastric electrical stimulator; GES; vomiting; nausea; bloating; postprandial fullness; epigastric pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical response to t-GES placement as measured by questionnaires

  1 year

• Develop a prospective registry in patients undergoing escalating t-GES

  1 year

• determine the feasibility and patient tolerability of endoscopic placement of t-GES

  1 year

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have been diagnosed with gatroparesis.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Hosptial

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum to be frozen

MeSH Terms

Conditions

Gastroparesis; Vomiting; Nausea

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• John M Wo, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 16, 2014
• Study Start: February 1, 2013
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: August 4, 2020

Record last verified: 2020-08

Locations

US (1)