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

Not yet recruiting

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

• Registration Number: NCT07197775
• Lead Sponsor: Endogenex, Inc.

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-26
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study First Posted: 2025-09-29
• Last Update Posted: 2025-09-29
• Study Start: 2025-10-01
• Primary Completion: 2032-05
• Study Completion: 2032-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Through 5 years	Incidence of device-related and/or procedure-related adverse events