Type 2 Diabetes Mellitus (T2DM)NCT07197775
Post-market SUrveiLlance RegiStry for the Endogenex System (Endogenex PULSE Registry)
An observational study of Type 2 Diabetes Mellitus (T2DM) and Type2Diabetes, run by Endogenex, Inc. at 4 sites in 2 countries.
Trial summary
This registry is designed to collect long-term data and support ongoing post-market surveillance of real-world data for the Endogenex System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Type2Diabetes, Diabetes Mellitus, Type 2
- How many people
- 500 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 11 Mar 2026to May 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who have been treated with the Endogenex System.
Who may be able to join
- Type 2 diabetes
- Have been treated with the Endogenex System
- Consented to participate in the Endogenex PULSE Registry
Who cannot join
- Unwilling or unable to attend study visits
- Unwilling or unable to provide medical records to study sites
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States3 sites
Care Access
Houston, Texas, 77054
Care Access
Quincy, Massachusetts, 02169
Care Access
Raleigh, North Carolina, 27607
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Type2Diabetes, Diabetes Mellitus, Type 2, Type 2 Diabetes, Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Endogenex System Treated | Participants treated with the Endogenex System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Incidence of device-related and/or procedure-related adverse events
Measured: Through 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start11 Mar 2026
- Primary completionMay 2032 (estimated)
- Study completionMay 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Endogenex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197775
- Sponsor's protocol ID
- 1419
- Status last verified
- Jun 2026
- First submitted
- 26 Sep 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endogenex PULSE Registry
- ClinicalTrials.gov ID
- NCT07197775
- Acronym / sponsor ID
- 1419
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Type2Diabetes, Diabetes Mellitus, Type 2, Type 2 Diabetes, Diabetes
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Endogenex, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- May 2032 (estimated)
- Study completion
- May 2032 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endogenex System Treated | – | –Participants treated with the Endogenex System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who have been treated with the Endogenex System.
Key inclusion criteria (3 listed)
- Type 2 diabetes
- Have been treated with the Endogenex System
- Consented to participate in the Endogenex PULSE Registry
Key exclusion criteria (2 listed)
- Unwilling or unable to attend study visits
- Unwilling or unable to provide medical records to study sites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of adverse events
Time frame: Through 5 years
Incidence of device-related and/or procedure-related adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus (T2DM) and Type2Diabetes, run by Endogenex, Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Through 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.