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

N/AEnrolling By InvitationNCT07197775

Endogenex, Inc.500 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Type 2 Diabetes Mellitus (T2DM)Type2Diabetes Diabetes Mellitus, Type 2 Type 2 Diabetes Diabetes

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Care Access

Quincy, Massachusetts, United States

Care Access

Raleigh, North Carolina, United States

Care Access

Houston, Texas, United States

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Outcomes

Primary Outcomes

Incidence of adverse events

Incidence of device-related and/or procedure-related adverse events

Time frame: Through 5 years

Data from ClinicalTrials.gov

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