- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03123809
Gastric Electrical Stimulation (GES) and Pyloroplasty for the Treatment of Gastroparesis (GES+PP)
Combined Gastric Electrical Stimulation (GES) and Pyloroplasty for the Treatment of Gastroparesis: Can Pyloroplasty be Effective Without GES?
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Irene Sarosiek, MD
- Phone Number: 915-215-5254
- Email: irene.sarosiek@ttuhsc.edu
Study Contact Backup
- Name: Richard McCallum, MD
- Phone Number: 915-215-5218
- Email: richard.mccallum@ttuhsc.edu
Study Locations
-
-
Texas
-
El Paso, Texas, United States, 79905
- Recruiting
- Texas Tech University Health Sciences Center
-
Contact:
- Irene Sarosiek, MD
- Phone Number: 915-215-5254
- Email: irene.sarosiek@ttuhsc.edu
-
Contact:
- Natalia Z. Vega, CCRC
- Phone Number: (915) 215-5270
- Email: natalia.vega@ttuhsc.edu
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Principal Investigator:
- Irene Sarosiek, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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). |
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 Names:
|
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). |
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Up to 7 months
|
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.
|
Up to 7 months
|
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)
|
up to 7 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Irene Sarosiek, MD, Texas Tech University Health Sciences Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E16156
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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