A Study to Evaluate the Safety and Tolerability of Virtual Reality to Treat Gastroparesis (NCT05079568) | Clinical Trial Compass
SuspendedNot Applicable
A Study to Evaluate the Safety and Tolerability of Virtual Reality to Treat Gastroparesis
Stopped: Pending funding
United States30 participantsStarted 2021-10-01
Plain-language summary
The purpose of this study is to determine if virtual reality therapy is safe and tolerable in treating gastroparesis.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Adult patients, men and women ages 18-75.
* Documented gastroparesis (idiopathic or diabetic).
* Patients who have had an upper endoscopy within the past 3 years not showing evidence of an organic disorder that could cause symptoms and a 4-hour scintigraphic gastric emptying scan showing evidence of delayed gastric emptying.
* Patients will be identified as direct referrals to the general GI clinic or the motility clinic, and will undergo screening history and physical examination by the PI or co-investigator.
Exclusion Criteria:
* Patients whose symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease).
* If the patients have known uncontrolled diabetes (HgbA1c \> 11), GERD, esophagitis, eosinophilic esophagitis, H. pylori, cannabinoid hyperemesis syndrome, celiac artery compression syndrome, or SMA syndrome.
* Patients with prior surgery to the esophagus, stomach or duodenum.
* Patients taking opioids will also be excluded.
* Alcohol and tobacco use will be assessed, as will the presence of psychiatric conditions, such as anxiety, depression, post-traumatic stress disorder, bipolar disorders, and eating disorders, such as anorexia nervosa and bulimia. However, no patient will be excluded based on reported substance use or presence of a psychiatric comorbidity, unless their psycho…