NCT07197775

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
70mo left

Started Mar 2026

Longer than P75 for all trials

Geographic Reach
2 countries

4 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Mar 2026May 2032

First Submitted

Initial submission to the registry

September 26, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

March 11, 2026

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2032

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

6.1 years

First QC Date

September 26, 2025

Last Update Submit

June 29, 2026

Conditions

Type 2 Diabetes Mellitus (T2DM)Type2DiabetesDiabetes Mellitus, Type 2Type 2 DiabetesDiabetes

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

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

    Through 5 years

Study Arms (1)

Endogenex System Treated

Participants treated with the Endogenex System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants who have been treated with the Endogenex System.

You may qualify if:

  • Type 2 diabetes
  • Have been treated with the Endogenex System
  • Consented to participate in the Endogenex PULSE Registry

You may not qualify if:

  • Unwilling or unable to attend study visits
  • Unwilling or unable to provide medical records to study sites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Care Access

Quincy, Massachusetts, 02169, United States

Location

Care Access

Raleigh, North Carolina, 27607, United States

Location

Care Access

Houston, Texas, 77054, United States

Location

St Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2025

First Posted

September 29, 2025

Study Start

March 11, 2026

Primary Completion (Estimated)

May 1, 2032

Study Completion (Estimated)

May 1, 2032

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)US(3)