Post-market SUrveiLlance RegiStry for the Endogenex System (Endogenex PULSE Registry)

Endogenex

Status: Not yet enrolling

Conditions: Type2Diabetes; Diabetes; Type 2 Diabetes Mellitus (T2DM); Type 2 Diabetes; Diabetes Mellitus, Type 2

Study type: Observational

Funder types: Industry

Identifiers

NCT07197775

1419

Details and patient eligibility

About

This registry is designed to collect long-term data and support ongoing post-market surveillance of real-world data for the Endogenex System.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Endogenex System Treated

Description:

Participants treated with the Endogenex System