GastroparesisGES+PPNCT03123809
Gastric Electrical Stimulation (GES) and Pyloroplasty for the Treatment of Gastroparesis
A study testing Gastric Electrical Stimulation (GES) System in people with Gastroparesis, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Gastric Electrical Stimulation (GES) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2017to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Organic or pseudo-obstruction, primary eating or swallowing disorders, positive pregnancy test result, psychogenic vomiting, peritoneal dialysis, drug dependent, morbid obesity, active malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center
El Paso, Texas, 79905
About this study
Official title: Combined Gastric Electrical Stimulation (GES) and Pyloroplasty for the Treatment of Gastroparesis: Can Pyloroplasty be Effective Without GES?
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.
Read the 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.
- Conditions
- Gastroparesis
- Being tested
- Gastric Electrical Stimulation (GES) System
- Keywords
- Diabetes Mellitus, gastroparesis, gastric electrical stimulation, pyloroplasty, Idiopathic -unknown etiology
- Medical subject headings
- Gastroparesis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric Electrical Stimulation (GES) SystemDevice
Also called Enterra II Therapy System INS Model 37800;
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: Gastric Electrical Stimulation (GES) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 7 months
Secondary outcomes (3)
Total Symptom Score (TSS) with severity and frequency of gastroparesis symptoms in each etiological subgroup of patients
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)
Measured: Up to 7 months
Associations between changes in gastric emptying and TSS
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.
Measured: Up to 7 months
Percentage of changes of gastric emptying retention of the radiolabeled meal (%) at 2-4 hrs
Scintigraphy Gastric Emptying Test (GET) will be recorded at baseline and after 3 months of randomized phase (GES ON or OFF)
Measured: up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start10 Jan 2017
- Primary completion15 Sep 2023
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Sarosiek, Texas Tech University Health Sciences Center, El Paso
- Investigators
- Irene Sarosiek, MD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123809
- Sponsor's protocol ID
- E16156
- Acronym
- GES+PP
- Status last verified
- May 2025
- First submitted
- 13 Apr 2017
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 41364437
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Gastric Electrical Stimulation (GES) and Pyloroplasty for the Treatment of Gastroparesis: Can Pyloroplasty be Effective Without GES?
- ClinicalTrials.gov ID
- NCT03123809
- Acronym / sponsor ID
- GES+PP / E16156
- Conditions
- Gastroparesis
- Keywords
- Diabetes Mellitus, gastroparesis, gastric electrical stimulation, pyloroplasty, Idiopathic -unknown etiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Gastric Electrical Stimulation (GES) ON | Active comparator | Device: Gastric Electrical Stimulation (GES) SystemGastric 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). |
| Gastric Electrical Stimulation (GES) OFF | Placebo comparator | Device: Gastric Electrical Stimulation (GES) SystemGastric 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Organic or pseudo-obstruction, primary eating or swallowing disorders, positive pregnancy test result, psychogenic vomiting, peritoneal dialysis, drug dependent, morbid obesity, active malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric Electrical Stimulation (GES) SystemAlso: Enterra II Therapy System INS Model 37800;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. | Device | Gastric Electrical Stimulation (GES) OFF, Gastric Electrical Stimulation (GES) ON |
Primary outcome
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.
3 secondary outcomes
Total Symptom Score (TSS) with severity and frequency of gastroparesis symptoms in each etiological subgroup of patients
Time frame: Up to 7 months
Associations between changes in gastric emptying and TSS
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Derived from this study: PubMed 41364437Sarosiek 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Sarosiek, MD principal investigator
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric Electrical Stimulation (GES) System in people with Gastroparesis, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of total gastroparesis symptom scores (TSS) (time frame: up to 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03123809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.