Gastric Electrical Stimulation (GES) and Pyloroplasty for the Treatment of Gastroparesis

NCT03123809 | Completed FDA Device

• 1 other identifier: E16156
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastroparesis

Keywords

Diabetes Mellitus; gastroparesis; gastric electrical stimulation; pyloroplasty; Idiopathic -unknown etiology

Outcome Measures

Primary Outcomes (1)

• Changes of total gastroparesis symptom scores (TSS)

  Severity and frequency of gastroparesis symptoms will be assess at baseline /surgery, after 3 months of randomized phase (GES ON or OFF), and at the end of 3 months of clinical follow up visit.

  up to 7 months

Secondary Outcomes (3)

• Total Symptom Score (TSS) with severity and frequency of gastroparesis symptoms in each etiological subgroup of patients

  Up to 7 months

• Associations between changes in gastric emptying and TSS

  Up to 7 months

• Percentage of changes of gastric emptying retention of the radiolabeled meal (%) at 2-4 hrs

  up to 7 months

Study Arms (2)

Gastric Electrical Stimulation (GES) ON

ACTIVE COMPARATOR

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).

Device: Gastric Electrical Stimulation (GES) System

Gastric Electrical Stimulation (GES) OFF

PLACEBO COMPARATOR

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).

Device: Gastric Electrical Stimulation (GES) System

Interventions

Gastric Electrical Stimulation (GES) System DEVICE

Implantable GES System will be turned ON as an active intervention providing electrical stimulation to the muscle of stomach for 6 months in patients from the first arm, versus 3 months only of active stimulation in patients who are randomized to be in the second arm of the study. GES works by utilizing following parameters: Current 5 mA; Pulse Width 330µsec; Rate 14 Hz; Time ON 0.1 sec; Time OFF 5.0 sec.

Also known as: Enterra II Therapy System INS Model 37800;

Gastric Electrical Stimulation (GES) OFF; Gastric Electrical Stimulation (GES) ON

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented diagnosis of GP for \> 1 year and refractoriness to anti-emetics and prokinetics; more than 7 emetic episodes per week;
• Delayed GE (gastric retention greater than 60% at 2 h and/or greater than 10% at 4 h) based on a 4-h standardized radionuclide solid meal test

You may not qualify if:

• Organic or pseudo-obstruction, primary eating or swallowing disorders, positive pregnancy test result, psychogenic vomiting, peritoneal dialysis, drug dependent, morbid obesity, active malignancy

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead

Study Sites (1)

Texas Tech University Health Sciences Center

El Paso, Texas, 79905, United States

Location

Related Publications (1)

• Sarosiek I, Bashashati M, Davis BR, Espino K, Vasquez D, Torelli R, Bright T, Sarosiek J, Diaz JR, Padilla O, Dwivedi AK, McCallum RW. Combined Gastric Electrical Stimulation and Pyloroplasty in Gastroparesis: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2546332. doi: 10.1001/jamanetworkopen.2025.46332.

  PMID: 41364437 DERIVED

MeSH Terms

Conditions

Gastroparesis; Diabetes Mellitus

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Irene Sarosiek, MD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patient and clinical investigators are going to be blinded in regards to the status of GES (if it is ON or OFF) for 3 months after surgery. One non-clinical investigator is assigned to serve as un-blind person , who is going to generate a master list of participants by dividing them into two groups based on their etiologies (diabetic or idiopathic). All effort would be to include similar numbers of idiopathic and diabetic patients in each intervention group based on a block randomization method, allowing for GES to be turned ON at the surgery, or it will stay OFF for the 3 month during the blind portion of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Based on confidential code set up for this study, there will be a randomized assigment for patients to have their GES devices turn ON or OFF. Half of these patients will be in each arm.

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 21, 2017
• Study Start: January 10, 2017
• Primary Completion: September 15, 2023
• Study Completion: October 30, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)