A Pilot and Feasibility Trial of G-POEM for Gastroparesis to Assess Safety, Physiological Mechanisms and Efficacy
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Gastroparesis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Outcomes Assessor)Masking Description: The endoscopy report and medical record will not state whether a GPOEM was performed, but instead state the following: "This patient was enrolled in a study protocol in which he/she was randomized to undergo upper endoscopy with GPOEM or no GPOEM". The endoscopist will document the actual procedure in a separate note that will be secured in his or her records for the study. After the sham or GPOEM procedure all patients will be admitted to the hospital for two days and follow the same protocol. Their care will be provided by members of the GI team who will be unaware of the assignment of the patient. If medical events necessitate knowledge of the nature of the intervention by care providers, a mechanism will be provided for urgent unmasking of the providers caring for the patient through the Scientific Data Research Center (SDRC). All facility and professional charges associated with the randomization procedure and interventions will be billed to the research study.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04869670
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Pankaj Pasricha, MD Johns Hopkins University
Get Well Soon