Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2026-03-06 @ 7:06 AM
Study NCT ID:
NCT02165059
Status:
RECRUITING
Last Update Posted:
2024-10-08
First Post:
2014-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GI Neuromuscular Pathology Prospective Registry
Sponsor:
Indiana University
Organization:
Study Overview
Official Title:
Indiana University GI Neuromuscular Pathology Prospective Registry
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this research study, biopsy samples will be collected to provide more insight into the underlying cause of the motility disorders, help direct further investigation into the cause of the underlying condition, provide future prognosis and predict response to gastric electrical stimulation (GES).
Detailed Description:
Biopsies will be collected from patients that have been diagnosed with gastroparesis (having nausea, retching, bloating and fullness of stomach) and are undergoing surgery for the GES implantation. These patients will serve as our study group population. Biopsy samples of those who do not have gastroparesis but are undergoing surgery on the digestive system will be collected after the patients consent to be on the trial. These patients will serve as our control group population. Detailed medical history will be collected and the study group patients will be asked to complete two questionnaire to assess the severity of the symptoms. They will be followed in the clinic at 6, 12, 18 and 24 months post implantation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: