Endogenex System for Type 2 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates the safety and effectiveness of the Endogenex System for treating type 2 diabetes. It targets individuals who participated in a previous study but did not receive the actual treatment. This trial may suit those with type 2 diabetes, an HbA1c level between 7.0 and 10.5%, and no recent insulin use. As an unphased trial, it provides a unique opportunity to contribute to valuable research and potentially benefit from an innovative treatment.
Do I need to stop taking my current medications for the trial?
The trial requires that you stop taking certain medications, such as insulin, GLP-1RA, GLP-1/GIP dual-agonists, vitamin K antagonists, P2Y12 inhibitors, NSAIDs, systemic glucocorticoids, medications affecting GI motility, and weight loss medications. If you are taking any of these, you may need to discontinue them before participating.
What prior data suggests that the Endogenex System is safe for Type 2 Diabetes?
Previous studies have shown the Endogenex System to be safe. Research indicates that patients have tolerated it well. One study found no serious unexpected medical problems related to the device or procedure. The treatment was also technically feasible, meaning it could be performed without major issues. This suggests the Endogenex System is generally safe for humans, based on the available data.12345
Why are researchers excited about this trial?
The Endogenex System is unique because it offers a novel approach to treating Type 2 Diabetes by targeting the underlying mechanisms of the disease. Unlike traditional treatments, which often focus on managing blood sugar levels through medication or insulin therapy, the Endogenex System is a procedure-based treatment that may offer a more direct intervention. Researchers are excited about its potential to provide a new, potentially more effective option for patients who struggle with current standard treatments.
What evidence suggests that the Endogenex System is effective for Type 2 Diabetes?
Research has shown that the Endogenex System, which participants in this trial will receive, may help treat type 2 diabetes. Previous studies found that patients experienced a significant drop in HbA1c levels, a measure of long-term blood sugar control. They also had lower fasting blood sugar levels and lost weight. Additionally, research demonstrated improved insulin sensitivity and better function of beta cells, which are crucial for managing diabetes. These results suggest that the Endogenex System could be a helpful treatment for people with type 2 diabetes.12346
Are You a Good Fit for This Trial?
This trial is for people with type 2 diabetes who were in the sham control group of the ReCET Study, have a BMI under 40, HbA1c between 7.0 and 10.5%, are not pregnant (if female), and can follow study rules.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Endogenex System procedure
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Endogenex System
Trial Overview
The study gives eligible participants access to the Endogenex System—a device-based treatment—to collect real-world data on its safety and how well it works after their initial participation in the ReCET Study.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Treatment arm will receive the Endogenex System procedure.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Endogenex, Inc.
Lead Sponsor
Citations
1.
endogenex.com
endogenex.com/announces-publication-of-regent-1-clinical-study-results-in-diabetes-obesity-and-metabolism/Endogenex Announces Publication of REGENT-1 Clinical ...
This group achieved a mean HbA1c reduction of 1.5%, a fasting plasma glucose reduction of 2.3 mmol/L (41.4 mg/dL), and body weight loss of 5.4 kg, representing ...
pulsENDO Treatment by Endogenex
The ReCET Study is a pivotal clinical study evaluating the use of the Endogenex system in people living with type 2 diabetes. The ReCET Study enrolled ...
Study Details | NCT06267391 | Safety and Effectiveness of ...
This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D)
4.
endogenex.com
endogenex.com/endogenex-announces-first-patient-enrolled-in-the-recet-clinical-study/Endogenex™ Announces First Patient Enrolled in the ...
Therapeutic interventions targeting the upper gastrointestinal tract are demonstrating improved outcomes for patients with type 2 diabetes. ...
Safety, feasibility, and dose‐dependent metabolic effects of ...
The Endogenex PEF–based duodenal therapy was safe, technically feasible, and associated with durable improvements in glycaemic control and body weight,
Endogenex to Present Data on Endoscopic Procedure for ...
Endogenex to Present Data on Endoscopic Procedure for Type 2 Diabetes at American Diabetes Association's (ADA) 85th Scientific Sessions.
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