View clinical trials related to Gastroparesis.
Filter by:Purpose: The study is a cross-sectional observational study designed to determine if eosinophilic gastritis (EG) results in gastric motility impairment. Hypothesis: Gastric dysfunction occurs in the natural history of EG but is underdiagnosed due, in part, to contraindications to the use of the standard meals used in gastric emptying studies.
A randomized clinical trial comparing endoscopic per-oral pyloromyotomy (POP) versus a control sham intervention (diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption) in patients with medically refractory gastroparesis.
In this prospective, randomized, open-label, parallel group trial, the safety and efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily will be compared with basal insulin once or twice daily plus pre-prandial insulin after 16 weeks of treatment in patients with type 1 diabetes. This trial will enable assessment of the clinically relevant endpoint of a change in HbA1c and Time in Range (TIR).
The purpose of this research is to evaluate the 12-month treatment effect of peroral endoscopic pyloromyotomy (G-POEM) vs. sham surgery in patients with gastroparesis that is not helped by medications and to analyze factors that may predict the outcome of the surgery.
Diabetic gastroparesis (DG) is an under recognized and significant complication of diabetes with lack of effective treatments. Recently, a 4-fold increase in hospitalizations has been seen in DG patients with refractory symptoms, defined as Grade 3 gastroparesis. A critical barrier to progress has been both a lack of pathophysiological understanding of DG and absence of effective treatments. Diabetic autonomic neuropathy is felt to be a key dysfunction in DG that causes gastric atony and segmental hypomotility of the small intestine. Autonomic testing of DG patients reveals significant sympathetic hypofunction, a feature distinguishing DG from diabetics with normal gastric emptying. Therefore, stimulation of the thoracic dorsal roots of the greater splanchnic nerve (sympathetic stimulation) could enhance gastric motility, as observed in animal models, and improve DG. Investigators have developed a novel, safe, noninvasive peripheral nerve treatment using repetitive magnetic stimulation, and have demonstrated improvement in fecal incontinence with neuropathy. The goal of this study is to build on our expertise to conduct a pilot, feasibility study by examining the effect of Thoracic Splanchnic Magnetic Neuromodulation Therapy (ThorS-MagNT) in patients with Grade 3 DG. The aims are to evaluate the safety, effectiveness and feasibility of ThorS-MagNT in patients with Grade 3 DG and to evaluate predictive factors of treatment. The central hypothesis is that ThorS-MagNT will improve sympathetic hypofunction, gastric motility, and spino-gut interactions, and thereby, improve symptoms of DG. ThorS-MagNT will be performed in 12 patients hospitalized with severe DG by using low-frequency, low-intensity repetitive magnetic stimulation, bilaterally, around T7 intravertebral space, twice a day for 5 days, with a total 1200 magnetic stimulations per treatment session at 1 Hz. The primary outcome is responder rate, defined as ≥20% reduction in the Gastroparesis Cardinal Symptom Index-daily diary (ANMS GCSI-DD) score. Secondary outcomes include subscores of the ANMS GSCI-DD, effects on gastric emptying time, Patient Global Impression of Improvement (PGI-I), safety, and tolerability. The impact of this work is to develop a novel, safe, and non-invasive treatment for severe DG that could result in a paradigm shift in management of DG.
The purpose of this program is to allow the use of domperidone in children from 12 to 21 years of age with symptoms related to motility disorders and Gastroesophageal reflux disease (GERD) who have failed all the standard treatments for their condition.
This study will assess changes in glycemic control in 40 patients with diabetes who undergo per-oral pyloromyotomy (POP) for medically refractory gastroparesis.
Objectives: To evaluate the efficacy of gastric per oral endoscopic pyloromyotomy (G-POEM) in the treatment of gastroparesis. Endpoints Primary endpoint: Clinical Efficacy Will be assessed by measurements of Gastroparesis Cardinal Symptoms Index (GCSI) score, Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) and the 36-Item Short Form Health Survey (SF-36). Outcome criteria will be measured at baseline, 1 month, 5 months, 7 months and 12 months. These criteria will be the mean total GCSI score, and SF-36 score based on the values recorded with a Likert scale. GES parameters will be the half gastric emptying time and the RPH2. Secondary endpoint: Safety Safety will be characterized by the incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or device that are experienced by study participants. In addition, safety assessments will be determined based on physical examination (vital signs) and laboratory tests during scheduled visits. Safety evaluations will also be performed to ensure no subsequent adverse events have occurred and to ensure any adverse events during the trial that are considered on-going are stable or have resolved. Safety will be assessed at 1 month, 5 months, 7 months and 12 months following the intervention. Other secondary endpoints will be technical success, nutritional status assessed by the measurement of the BMI, pre-albumin and albumin levels and for diabetics the HbA1c. These criteria will be measured at baseline, 1 month, 5 months, 7 months and 12 months. Overall design This will be a prospective, sham-randomized, monocentric, interventional, efficacy study. Once baseline eligibility criteria have been met, a first endoscopy under general anesthesia is proposed to the patients. Patients will be randomized blindly in a 1/1 fashion design between the sham arm and the GPOEM arm. At the time of the general anesthesia, a sealed envelope will be opened. Subjects will have a second endoscopy under general anesthesia 6 months later and the sham arm will then beneficiate from a GPOEM procedure and the GPOEM arm a sham procedure. Then, all the patients will be followed for another 6 months. GCSI score, PAGI-SYM, SF36 will be collected at screening, 1,5,7 and 12 months. GES RPH2, RPH4 and half emptying time will be collected at screening, 5 months and 12 months. Study procedures Description procedure in the GPOEM arm: The intervention will be performed under general anesthesia with tracheal intubation in supine position. GPOEM is performed with the following steps: -i: submucosal injection; -ii: mucosal incision upstream the pylorus followed by submucosal tunneling; -iii: antropyloromyotomy; -iv: closure of the tunnel access. Description procedure in the SHAM arm: A diagnostic upper digestive tract endoscopy will be performed under general anesthesia with tracheal intubation in supine position, injection of 1 cc of saline at four quadrants of the pylorus. Post-operative management Once the patients recovered from anesthesia after the procedure, they were administrated analgesics and anti-emetics as needed and esomeprazole 80 mg daily systematically to protect the mucosal access and tunnel from ulceration. Patients will be kept fasted for the first postoperative day (POD 1). In the absence of adverse events, patients will be allowed to resume liquid oral intake for 1 day, a soft-ground diet for 2 additional days, and finally a normal diet. They will be discharged after POD 1 in the absence of adverse events, with a prescription of esomeprazole 40 mg daily by mouth for 1 month and dietary instructions. After 6 months, another endoscopy under general anesthesia will be performed with the SHAM and GPOEM arms are interchanged. After the G-POEM / SHAM procedure, all patients will be rigorously evaluated in the same fashion. They will be assessed clinically before being discharged (POD 1) and then at 1 month and 5 months after the intervention with a clinical examination that included determination of the severity of the symptoms and total GCSI score, PAGI-SYM, SF-36. A GES will be performed at 5 months and 12 months.
Develop a registry (list of patients) with accurate clinical motility diagnosis. This registry will help the doctors to identify the patients with specific disease conditions. It will also help in promoting future research in gastroenterology motility disorders
Gastric Per-Oral Endoscopic Myotomy (G-POEM) is a procedure for the Treatment of Gastroparesis.