GES + Pyloroplasty for Gastroparesis
(GES+PP Trial)

Recruiting in Palo Alto (17 mi)

Overseen byIrene Sarosiek, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Texas Tech University Health Sciences Center, El Paso

Trial Summary

What is the purpose of this trial?Gastroparesis (GP) is describing a condition when stomach does not empty as fast as it should. This fact creates the situation, when food stays in the stomach for a long time and it causes symptoms of nausea, vomiting, loss of appetite, bloating, inability to finish normal size meal and abdominal pain. There are not many drugs available to treat this condition and majority of gastroparetic patients are not responding well to them after they are on it for some time. Many investigators are able to implant Gastric Stimulator System (GES) under FDA approved status of Humanitarian Device Exemption (HDE) definition. In the last few years it became possible to add another surgical procedure, which is called pyloroplasty (making bigger opening on the end of stomach), may help even more as it is also increasing the rate of the emptying of the stomach. Therefore this study is proposing to evaluate if GES in combination with pyloroplasty is much better than pyloroplasty alone. For this reason, two of these procedures will be introduced surgically at the same time, but GES devices will not be turn ON in half of these participants for 3 months. After that time all subjects will have their devices turned ON. All subjects will be asked to evaluate their symptoms of gastroparesis and their quality of life during clinical visits, and investigators will conduct pathological analyses of tissue obtained during surgery.

Eligibility Criteria

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.

Inclusion Criteria

I experience vomiting more than 7 times a week.

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.

+1 more

Exclusion Criteria

I am extremely overweight.

I am on peritoneal dialysis.

You rely on a specific medication.

+5 more

Participant Groups

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.

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).