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Device

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

Must not have

Morbid obesity

Peritoneal dialysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 months

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience vomiting more than 7 times a week.

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I have had gastroparesis for over a year and treatments haven't worked.

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I have had gastroparesis for over a year and treatments haven't stopped my vomiting.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am extremely overweight.

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I am on peritoneal dialysis.

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I have a blockage in my intestines.

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I have a condition that affects my ability to eat or swallow.

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I currently have cancer.

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I experience vomiting that's caused by stress or mental factors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes of total gastroparesis symptom scores (TSS)

Secondary study objectives

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

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).

0 / 9Eligibility criteria met