GI Neuromuscular Pathology Prospective Registry
ConditionGastroparesis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-90
SponsorIndiana University
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Patients who have been diagnosed with gastropareiss and are undergoing surgery for full thickness biopsy GES implantation willl serve as our study group, Patients who are undergoing surgery on the digestive system but do not have gastroparesis, will serve as our control group.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Surgical Full Thickness Biopsy
Procedure/SurgeryEligible subjects will undergo a surgical full thickness biopsy of the stomach and/or proximal jejunum as part of their planned surgery.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: GI Neuromuscal Disorder Cohort1 intervention
Group B: GI Surgery Patients without neuromuscal disorders (control) cohort1 intervention
Trial outcomes
Primary outcomes
1
Biologic Markers As Predictors for Gastric Electrical Stimulation Outcomes
To determine if ICC abnormalities of the stomach and proximal jejunum can be used as a biologic marker in predicting clinical outcome in patients undergoing surgical implantation of gastric electrical stimulation (GES) for severe gastroparesis.
Time frame
from implantation to 6 months afterSponsors and contacts
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Source ClinicalTrials.gov