Diabetes, Diabetes Mellitus, Type 2, Type2Diabetes, Type 2 Diabetes, Type 2 Diabetes Mellitus (T2DM)
Conditions
Brief summary
This registry is designed to collect long-term data and support ongoing post-market surveillance of real-world data for the Endogenex System.
Detailed description
This is an observational registry that is designed to facilitate long-term patient follow-up for up to 5 years after an Endogenex procedure. It is structured to enable systematic longitudinal data collection on the safety and long-term clinical outcomes associated with the Endogenex System.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Type 2 diabetes * Have been treated with the Endogenex System * Consented to participate in the Endogenex PULSE Registry
Exclusion criteria
* Unwilling or unable to attend study visits * Unwilling or unable to provide medical records to study sites
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | Through 5 years | Incidence of device-related and/or procedure-related adverse events |
Countries
Australia, United States