An interventional study of Gastric Electrical Stimulation (GES) System in Gastroparesis, sponsored by Texas Tech University Health Sciences Center, El Paso. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Texas Tech University Health Sciences Center, El Paso · Not applicable, Interventional, and Treatment
Among 184 studies in Gastroparesis with a site in United States — 33 open to participants now, 41 under way, 2 of them phase 3. Gastroparesis · United States.
Among the 184 studies in Gastroparesis with a site in United States, this one is the 59th largest by enrollment of the 136 interventional ones that give a count, is one of 7 that started in 2017, is one of 68 with no phase, and was the 81st registered.
323 studies on the registry are indexed under Gastroparesis; 76 are open to participants now.
Browse Gastroparesis studies →33 of the 184 studies in Gastroparesis with a site in United States are open now. Recruiting first, the newest first:
Evan (Huiliang) Wang · Sites in United States
Ages 18–70
Indiana University · Sites in United States
Ages 18+
Ohio State University · Sites in United States
Ages 18+
Ohio State University · Sites in United States
Ages 18–65
Viral N. Shah · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 50 Gastroparesis studies recruiting now, 25 (50%) set no upper age limit and 15 (30%) stop at 75 or younger; 8 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
184 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 42 · Phase 3 14 · Phase 4 6
First in 2002; this study’s year is marked. 7 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 44 is close to the median of 42 across 215 interventional studies indexed under Gastroparesis.
Median enrollment 36 across the 136 interventional studies, 108 across the 39 observational. Of the 124 that completed or were terminated, 63 (51%) have results posted.
This tab as a report to print or save as PDF → With an account.
55 of 184 have an industry lead sponsor. The 10 most frequent:
Texas Tech University Health Sciences Center, El Paso is the lead sponsor of 43 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Texas Tech University Health Sciences Center, El Paso has 2 studies filed under Gastroparesis — fewer than ten, so there is no comparison to draw.
14 of the studies in Gastroparesis with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01696734Phase 3M.D. Anderson Cancer CenterDomperidone in Treating Patients With Gastrointestinal Disorders | 2027-10-31 |
| NCT04506593Indiana UniversityIndiana University Gastrointestinal Motility Diagnosis Registry | 2026-11 |
| NCT06046833Samita GargContinuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes | 2026-12 |
| NCT02165059Indiana UniversityGI Neuromuscular Pathology Prospective Registry | 2026-12 |
| NCT04282317Indiana UniversityMagnetic Resonance Imaging of the Brain and Stomach in Healthy Volunteers and Gastroparesis | 2026-12-31 |
Among the 184 studies in Gastroparesis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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) 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.
Also known as: Enterra II Therapy System INS Model 37800;
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.
Time frame: up to 7 months
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)
Time frame: 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.
Time frame: 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)
Time frame: up to 7 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2017 to primary completion in Sep 2023, 80 months.
Of 56 non-industry interventional studies with no phase under Gastroparesis, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 59. This study's 80 months is above that.
Counting every sponsor, half of 65 studies reached it within 28 months; a quarter within 11 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Texas Tech University Health Sciences Center, El Paso