Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes (ReCET)

August 3, 2026 updated by: Endogenex, Inc.

A Multicenter, Randomized, Double-blind, Sham-controlled Study for Assessing the Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes (ReCET Study)

This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective, multi-center, randomized, double-blind, sham-controlled, adaptive study enrolling individuals with type 2 diabetes inadequately controlled on non-insulin glucose-lowering medications. Participants will be randomized to receive the Endogenex therapy or sham procedure consisting of device insertion without treatment. Participants will be followed for 6 months for the primary endpoint and 12 months in total. After 12 months, participants randomized to the sham arm may cross-over to receive the Endogenex procedure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2006
        • Royal Prince Alfred Hospital
      • Double Bay, New South Wales, Australia, 2028
        • The BMI Clinic
      • Saint Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Eastern Health - Box Hill Hospital
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent's Hospital Melbourne
      • Heidelberg, Victoria, Australia
        • Austin Health
      • Melbourne, Victoria, Australia, 3004
        • Baker Heart and Diabetes Institute
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Central Alabama Research
      • Birmingham, Alabama, United States, 35205
        • University of Alabama
    • California
      • Gardena, California, United States, 90247
        • Velocity Clinical Research, Gardena
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90065
        • UCLA
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital Presbyterian - Digestive Health Institute
    • Florida
      • Hallandale, Florida, United States, 33009
        • Velocity Clinical Research, Hallandale Beach
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • Miami, Florida, United States, 33166
        • University of Miami
      • Miami, Florida, United States, 33166
        • Universal Axon Clinical Research LLC
      • Miami Beach, Florida, United States, 33140
        • Quantum Clinical Research
      • Ocoee, Florida, United States, 34761
        • West Orange Endocrinology
      • Orlando, Florida, United States, 32806
        • Orlando Health
      • Orlando, Florida, United States, 32804
        • Advent Health
      • West Palm Beach, Florida, United States, 33407
        • Health Synergy Clinical Research
    • Illinois
      • Evanston, Illinois, United States, 60201
        • NorthShore University Health System
    • Iowa
      • Clive, Iowa, United States, 50325
        • Heartland Medical Research, Inc.
      • West Des Moines, Iowa, United States, 50266
        • Iowa Diabetes and Endocrinology Research Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • John Hopkins
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Health System
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson Medical School
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University- Wexner Medical Center
    • Texas
      • Austin, Texas, United States, 78712
        • Dell Medical School
      • Austin, Texas, United States, 78745
        • IMA Clinical Research - Austin
      • Austin, Texas, United States, 78613
        • Velocity Clinical Research - Austin
      • Bellaire, Texas, United States, 77401
        • The University of Texas Health Science Center at Houston
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Research, Dallas
      • Dallas, Texas, United States, 75235
        • University of Texas Southwestern Medical School - William P. Clements Jr. University Hospital
      • Dallas, Texas, United States, 75235
        • Southwest Medical Center
      • DeSoto, Texas, United States, 75115
        • Epic Medical Research
      • Houston, Texas, United States, 77030
        • Houston Methodist Research Institute
      • Houston, Texas, United States, 77054
        • Juno Research, LLC
      • Round Rock, Texas, United States, 78681
        • Texas Diabetes & Endocrinology, P.A.
      • San Antonio, Texas, United States, 78229
        • Diabetes & Glandular Disease Clinic, P.A.
      • San Antonio, Texas, United States, 78229
        • IMA Clinical Research - San Antonio
      • Sugar Land, Texas, United States, 77479
        • Mt. Olympus Medical Research

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 22- 70 years of age, inclusive.
  • T2D diagnosis for at least 6 months.
  • HbA1C of 7.5-10.5%, inclusive, determined by the central laboratory.
  • BMI 27-40 kg/m2, inclusive.
  • On 2-4 non-insulin glucose lowering mediations or on monotherapy with either GLP-1 or GLP-1/GIP medications, with no changes in medication or dosing for at least 12 weeks prior to the baseline visit.
  • Individualized metabolic surgery (IMS) score ≤ 95.
  • Weight stability (≤5% weight change) for at least 12 weeks prior to the screening visit.
  • Agree not to donate blood during participation in the study.
  • Able to comply with study requirements and understand and sign the Informed Consent Form.
  • Women of childbearing potential must be not pregnant and using an acceptable method of contraception throughout the study.
  • Willing and able to comply with study visits and study tasks as required per protocol.

Exclusion Criteria:

  • Diagnosed with type 1 diabetes.
  • History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
  • Fasting serum C-peptide <1 ng/mL (333pmol/l).
  • Current use of insulin, or previous use of any types of insulin for >1 month at any time (except for treatment of gestational diabetes) in last 2 years.
  • Hypoglycemic unawareness.
  • History of ≥1 severe hypoglycemia episode in past 6 months
  • Discontinuation of a GLP-1RA or a GLP-1/GIP dual-agonist within 6 months of the screening visit following at least one month of treatment.
  • Known autoimmune disease, including but not limited to, celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder, or as evidenced by a positive anti-glutamic acid decarboxylase (GAD) test.
  • Previous GI surgery that has changed GI anatomy or could limit treatment of the duodenum, such as Billroth 2, Roux-en-Y gastric bypass, gastric band or other similar procedures or conditions.
  • Known history of a structural or functional disorder of the upper GI tract that may impede passage of the device through the upper GI tract or increase risk of tissue damage during an endoscopic procedure, including eosinophilic esophagitis, stricture/stenosis, varices, diverticula, or other disorder of the esophagus, stomach and duodenum.
  • History of gastroparesis.
  • Acute gastrointestinal illness in the last 7 days.
  • Known history of irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease and Celiac disease.
  • History of chronic or acute pancreatitis.
  • Active hepatitis or active liver disease, or alanine aminotransferase (ALT) level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory at screening visit. Patients with NAFLD are eligible if their ALT level is ≤3.0 times the ULN.
  • Current use of vitamin K antagonists, such as warfarin, or current use of direct-action oral anticoagulants (DOCAs) that cannot be safely discontinued periprocedurally.
  • Current use of P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued for 7 days before the procedure.
  • Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) from treatment through 4 weeks following the procedure. Alternative use of acetaminophen and low dose aspirin is allowed.
  • Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 12 weeks prior to the screening visit.
  • Use of medications known to affect GI motility (e.g. metoclopramide/ Reglan)
  • Current use of weight loss medications such as Saxenda [liraglutide ], Xenical® [orlistat], Acutrim® [phenylpropanolamine], Sanorex® [mazindol], Adipex® [phentermine], BELVIQ® [lorcaserin], Qsymia® [phentermine/topiramate combination], Contrave® [naltrexone/bupropion], or other weight loss medications including over-the-counter [OTC] medications [for example, Allī®]) or have discontinued weight loss medications within 6 months.
  • Participation in any structured weight loss program or endoscopic weight loss intervention within 6 months of the screen visit.
  • Persistent anemia, defined as hemoglobin <10 g/dL.
  • Known history of hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
  • History of blood donation or transfusion within 3 months prior to the Screening Visit.
  • Unstable or paroxysmal cardiac arrhythmia.
  • Any of the following cardiovascular conditions within 6-months prior to screening visit: acute myocardial infarction, cerebrovascular accident (stroke), hospitalization due to congestive heart failure.
  • History of valvular heart disease or chronic heart failure (NYHA III or IV).
  • Estimated glomerular filtration rate (eGFR) ≤ 45 ml/min/1.73m2 calculated by CKD-EPI Creatinine Equation as determined by the central laboratory.
  • Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the participant a poor candidate for clinical trial participation in the opinion of the investigator.
  • History of secondary hypothyroidism or inadequately controlled primary hypothyroidism (TSH value outside the normal range at screening).
  • Presence of any implanted electronic devices that cannot be turned off during the procedure
  • Presence of duodenal or biliary stents.
  • Not a candidate for upper GI endoscopy or general anesthesia.
  • Active illicit substance abuse or alcoholism (>2 drinks/day regularly).
  • Active malignancy within the last 5 years (excluding non-melanoma skin cancers).
  • Women who are breastfeeding.
  • Participating in another ongoing clinical trial of an investigational drug or device.
  • Binge eating disorder, or any other mental or physical condition which, in the opinion of the study investigator, makes the participant a poor candidate for clinical trial participation.
  • Critically ill or has a life expectancy <5 years.
  • Are investigator site personnel directly affiliated with this study and/or their immediate family member. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Control Arm
Control Arm will receive a sham procedure.
Device: Sham Procedure
The Control arm will receive a sham procedure. The sham procedure consists of placing the Endogenex catheter as described above without therapy applied. Participants will be followed for 12 months post procedure. They will be offered the Endogenex therapy after 12 months.
Experimental: Endogenex Arm
Treatment Arm will receive the Endogenex procedure.
Device: Endogenex Treatment
Treatment arm will receive the Endogenex therapy. The procedure utilizes the Endogenex catheter to deliver non-thermal pulsed electric field to the first portion of the small intestine (duodenum) to induce cell regeneration. The catheter is introduced to the duodenum through the mouth using a guide wire and the therapy is applied to treat the duodenum. Participants will be followed for 12 months post procedure.
Other Names:
  • duodenal mucosal resurfacing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 6 months post-procedure
Change in HbA1c (%) from baseline to Month 6
6 months post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 12 months post-procedure
Change in HbA1c (%) from baseline to Month 12
12 months post-procedure
HbA1c ≤7.0% without requiring rescue medication
Time Frame: 6 months post-procedure
Proportion of participants with HbA1c ≤7.0% without requiring rescue medication
6 months post-procedure
Time-in Range (TIR)
Time Frame: 6 months post-procedure
Proportion of participants with TIR ≥70%
6 months post-procedure
Total body weight loss (%TBWL)
Time Frame: 6 months post-procedure
Percent total body weight loss (%TBWL) from baseline to Month 6
6 months post-procedure
Incidence of adverse events
Time Frame: 6 months post-procedure
Incidence of adverse events, device- and/or procedure-related adverse events, and serious device- and/or procedure-related adverse events, and adverse events of special interest.
6 months post-procedure

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Endogenex, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Lian Cunningham, MD, PhD, lcunningham@endogenex.com

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 898 (HCL)

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

Yes

product manufactured in and exported from the U.S.

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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