ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 43 for:    Recruiting, Not yet recruiting, Available Studies | "Gastroparesis"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03123809
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Irene Sarosiek, Texas Tech University Health Sciences Center, El Paso

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.

Condition or disease Intervention/treatment Phase
Gastroparesis Device: Gastric Electrical Stimulation (GES) System Not Applicable

Detailed Description:

GES system (Enterra Therapy) involves surgical implantation of a pulse generator in the abdominal wall and 2 electrodes into the muscularis propria of the stomach. Well established procedure, called pyloroplasty, will be performed during the implantation of GES system, therefore all participants will have both surgeries done at the same time. Half of them will be randomized to keep GES ON after surgery, and other half will have GES turned OFF for 3 months.

Both groups will be followed for additional 3 more months. Study related questionnaires and diagnostic/ clinical tests will be obtained at all points of interest of this study.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Combined Gastric Electrical Stimulation (GES) and Pyloroplasty for the Treatment of Gastroparesis: Can Pyloroplasty be Effective Without GES?
Actual Study Start Date : January 10, 2017
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Gastric Electrical Stimulation (GES) ON

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
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.
Other Name: Enterra II Therapy System INS Model 37800;

Placebo Comparator: Gastric Electrical Stimulation (GES) OFF

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
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.
Other Name: Enterra II Therapy System INS Model 37800;




Primary Outcome Measures :
  1. Changes of total gastroparesis symptom scores (TSS) [ Time Frame: up to 7 months ]
    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.


Secondary Outcome Measures :
  1. Total Symptom Score (TSS) with severity and frequency of gastroparesis symptoms in each etiological subgroup of patients [ Time Frame: Up to 7 months ]
    TSS in diabetic and idiopathic sub-group of gastroparetic patients will be compared and analyzed (if adequate number of patients will be in each subgroup)

  2. Associations between changes in gastric emptying and TSS [ Time Frame: Up to 7 months ]
    Statistical analyses of any possible correlation between retention of GET study meal and gastroparesis symptoms will be asses at the end of randomized phase of the study.

  3. Percentage of changes of gastric emptying retention of the radiolabeled meal (%) at 2-4 hrs [ Time Frame: up to 7 months ]
    Scintigraphy Gastric Emptying Test (GET) will be recorded at baseline and after 3 months of randomized phase (GES ON or OFF)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123809


Contacts
Contact: Irene Sarosiek, MD 915-215-5254 irene.sarosiek@ttuhsc.edu
Contact: Richard McCallum, MD 915-215-5218 richard.mccallum@ttuhsc.edu

Locations
United States, Texas
Texas Tech University Health Sciences Center Recruiting
El Paso, Texas, United States, 79905
Contact: Irene Sarosiek, MD    915-215-5254    irene.sarosiek@ttuhsc.edu   
Contact: Natalia Z. Vega, CCRC    (915) 215-5270    natalia.vega@ttuhsc.edu   
Principal Investigator: Irene Sarosiek, MD         
Sponsors and Collaborators
Texas Tech University Health Sciences Center, El Paso
Investigators
Principal Investigator: Irene Sarosiek, MD Texas Tech University Health Sciences Center

Responsible Party: Irene Sarosiek, Professor of Medicine, Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier: NCT03123809     History of Changes
Other Study ID Numbers: E16156
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Irene Sarosiek, Texas Tech University Health Sciences Center, El Paso:
Diabetes Mellitus
gastroparesis
gastric electrical stimulation
pyloroplasty
Idiopathic -unknown etiology

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms