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GES + Pyloroplasty for Gastroparesis (GES+PP Trial)
N/A
Recruiting
Led By Irene Sarosiek, MD
Research Sponsored by Texas Tech University Health Sciences Center, El Paso
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
More than 7 emetic episodes per week
Documented diagnosis of GP for > 1 year and refractoriness to anti-emetics and prokinetics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 months
Awards & highlights
GES+PP Trial Summary
This trial is looking at whether a gastric stimulator system, in combination with pyloroplasty, is better than pyloroplasty alone for treating gastroparesis.
Who is the study for?
This trial is for individuals who have been diagnosed with gastroparesis for over a year and haven't responded well to standard treatments. They should experience more than seven episodes of vomiting per week and have delayed stomach emptying as shown by tests. People can't join if they are on peritoneal dialysis, drug-dependent, extremely overweight, or have conditions that block digestion, swallowing disorders, are pregnant, suffer from psychogenic vomiting or active cancer.Check my eligibility
What is being tested?
The study is testing whether combining Gastric Electrical Stimulation (GES) with pyloroplasty surgery provides better relief from gastroparesis symptoms compared to just the surgery alone. Initially, half of the participants will receive both interventions but only the surgery will be active; after three months all participants will have GES activated.See study design
What are the potential side effects?
Potential side effects may include discomfort at the implant site for GES, surgical complications like infection or bleeding from pyloroplasty. There might also be changes in bowel movements or digestion due to alterations in stomach function.
GES+PP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience vomiting more than 7 times a week.
Select...
I have had gastroparesis for over a year and treatments haven't worked.
Select...
I have had gastroparesis for over a year and treatments haven't stopped my vomiting.
GES+PP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes of total gastroparesis symptom scores (TSS)
Secondary outcome measures
Associations between changes in gastric emptying and TSS
Percentage of changes of gastric emptying retention of the radiolabeled meal (%) at 2-4 hrs
Total Symptom Score (TSS) with severity and frequency of gastroparesis symptoms in each etiological subgroup of patients
GES+PP Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Gastric Electrical Stimulation (GES) ONActive Control1 Intervention
Gastric Electrical Stimulation (GES) system involves surgical implantation of a pulse generator in the abdominal wall and 2 electrodes into the muscularis propria of the stomach.
After surgery this group of GP patients will have their GES programed and system will be turned ON for 3 months during a double-blind phase of the study. This step will be followed with additional 3 months of active stimulation (GES System will be turned ON) as it is described in the protocol.Therefore all subjects in this arm will receive overall 6 months of intervention, which will be provided by the active stimulation of GES System (GES turned ON for 6 months).
Group II: Gastric Electrical Stimulation (GES) OFFPlacebo Group1 Intervention
Gastric Electrical Stimulation (GES) system involves surgical implantation of a pulse generator in the abdominal wall and 2 electrodes into the muscularis propria of the stomach.
After surgery this group of GP patients will have their GES programed and system will be turned OFF for 3 months.This step will be followed with additional 3 months of active stimulation (GES System will be turned ON) as it is described in the protocol. Therefore all subjects in this arm will receive first 3 months of non GES intervention (GES System OFF), and 3 following months of active intervention which will be provided by the stimulation of GES System (GES turned ON for 3 months).
Find a Location
Who is running the clinical trial?
Texas Tech University Health Sciences Center, El PasoLead Sponsor
49 Previous Clinical Trials
5,070 Total Patients Enrolled
6 Trials studying Gastroparesis
1,129 Patients Enrolled for Gastroparesis
Irene Sarosiek, MDPrincipal Investigator - Texas Tech University Health Sciences Center
Texas Tech University Health Sciences Center, El Paso
3 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Gastroparesis
40 Patients Enrolled for Gastroparesis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience vomiting more than 7 times a week.I am extremely overweight.I have had gastroparesis for over a year and treatments haven't worked.I have had gastroparesis for over a year and treatments haven't stopped my vomiting.I am on peritoneal dialysis.You rely on a specific medication.I have a blockage in my intestines.I have a condition that affects my ability to eat or swallow.You are pregnant.I currently have cancer.Your stomach takes too long to empty food based on a special test with a radioactive meal.I experience vomiting that's caused by stress or mental factors.
Research Study Groups:
This trial has the following groups:- Group 1: Gastric Electrical Stimulation (GES) OFF
- Group 2: Gastric Electrical Stimulation (GES) ON
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Gastroparesis Patient Testimony for trial: Trial Name: NCT03123809 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the research team currently recruiting participants?
"Correct. Evidence hosted on clinicaltrials.gov shows that this medical study, which was initially posted on 10th January 2017, is actively recruiting patients. Approximately 50 participants need to be sourced from 1 healthcare centre."
Answered by AI
Does the research project accept participants over 30 years of age?
"This clinical trial has a cutoff of 18 years as the minimum age for enrolment and 65 as the maximum. For those younger than 18, there are 4 separate studies available; meanwhile, 27 different trials exist to accommodate individuals that are over 65."
Answered by AI
How many individuals can partake in this research endeavor?
"Affirmative. According to clinicaltrials.gov, the trial which was first listed on 10th January 2017 is currently searching for 50 volunteers from 1 site. The details of this study have been most recently revised on 8th April 2022."
Answered by AI
Who meets the eligibility criteria for this clinical examination?
"To be admitted to this clinical trial, candidates must have gastroparesis and fall into the demographic range of 18-65 years old. At present, approximately 50 study participants are being sought out."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Texas Tech University Health Sciences Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
3+
Why did patients apply to this trial?
I’m tired o f the medication not working it’s progressing more and more and I’m so done with the quality of life I have right now. I need help.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How long will screening take? Will I stay on site durning the trial?
PatientReceived no prior treatments
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