Post-market SUrveiLlance RegiStry for the Endogenex System (Endogenex PULSE Registry)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus (T2DM), Type2Diabetes, Diabetes Mellitus, Type 2, Type 2 Diabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Endogenex PULSE Registry
Overview
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.
Primary outcome measures
- Incidence of adverse events [Time frame: Through 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- Care Access — Quincy
- Care Access — Raleigh
- Care Access — Houston
Australia · 1 center
- St Vincent's Hospital Melbourne — Fitzroy
Identifiers
NCT: NCT07197775 · 1419