Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-28 @ 8:50 PM
Study NCT ID:
NCT05079568
Status:
SUSPENDED
Last Update Posted:
2025-06-12
First Post:
2021-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Tolerability of Virtual Reality to Treat Gastroparesis
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
"A Pilot Study to Assess the Safety, Tolerability and Efficacy of Virtual Reality for the Treatment of Gastroparesis"
Status:
SUSPENDED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Pending funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if virtual reality therapy is safe and tolerable in treating gastroparesis.
Detailed Description:
After informed consent patients will be randomized to a 4 week treatment program comparing active VR treatment to sham VR treatment. Symptoms will be measured at baseline and at 2 and 4 weeks using validated questionnaires. A short questionnaire will be answered daily to evaluate changes in nausea.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: