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

September 26, 2025 updated by: Endogenex, Inc.

Endogenex PULSE Registry

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

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants who have been treated with the Endogenex System.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Endogenex System Treated
Participants treated with the Endogenex System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Through 5 years
Incidence of device-related and/or procedure-related adverse events
Through 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endogenex, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2025

Primary Completion (Estimated)

May 1, 2032

Study Completion (Estimated)

May 1, 2032

Study Registration Dates

First Submitted

September 26, 2025

First Submitted That Met QC Criteria

September 26, 2025

First Posted (Estimated)

September 29, 2025

Study Record Updates

Last Update Posted (Estimated)

September 29, 2025

Last Update Submitted That Met QC Criteria

September 26, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1419

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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