NCT02165059

GI Neuromuscular Pathology Prospective Registry

Indiana University GI Neuromuscular Pathology Prospective Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 6 Months – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gastroparesis

Interventions

Type	Name	Description
PROCEDURE	Surgical Full Thickness Biopsy	Eligible subjects will undergo a surgical full thickness biopsy of the stomach and/or proximal jejunum as part of their planned surgery.

Timeline

• Start date: 2013-12-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2014-06-17
• Last updated: 2024-10-08

Locations

1 site across 1 country: United States