Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes
NCT ID: NCT06267391
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
264 participants
INTERVENTIONAL
2024-05-01
2026-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Trial to Evaluate Safety, Feasibility and Efficacy of the ReCET Procedure (EMINENT-2)
NCT05984238
Safety and Feasibility of Novel Therapy for Duodenal Mucosal Regeneration for Type II Diabetes
NCT05014204
Study Evaluating the Safety and Feasibility of Endoscopic Duodenal Injections of Autologous Mesenchymal Stem Cells
NCT07344324
The Role of Small Intestinal Endocrine Cells in Type 2 Diabetic Hyperglucagonemia
NCT00639613
Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes
NCT03653091
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ReCET Arm
Treatment Arm will receive the ReCET procedure.
ReCET Treatment
Treatment arm will receive the ReCET therapy. The ReCET procedure utilizes the ReCET 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.
Control Arm
Control Arm will receive a sham procedure.
Sham Procedure
The Control arm will receive a sham procedure. The sham procedure consists of placing the ReCET catheter as described above without therapy applied. Participants will be followed for 12 months post procedure and will be offered cross-over to receive the ReCET therapy after 12 months.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ReCET Treatment
Treatment arm will receive the ReCET therapy. The ReCET procedure utilizes the ReCET 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.
Sham Procedure
The Control arm will receive a sham procedure. The sham procedure consists of placing the ReCET catheter as described above without therapy applied. Participants will be followed for 12 months post procedure and will be offered cross-over to receive the ReCET therapy after 12 months.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
22 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Endogenex, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama
Birmingham, Alabama, United States
Central Alabama Research
Birmingham, Alabama, United States
Velocity Clinical Research, Gardena
Gardena, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian - Digestive Health Institute
Newport Beach, California, United States
Velocity Clinical Research, Panorama City
Panorama City, California, United States
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Universal Axon Clinical Research LLC
Miami, Florida, United States
University of Miami
Miami, Florida, United States
Quantum Clinical Research
Miami Beach, Florida, United States
West Orange Endocrinology
Ocoee, Florida, United States
Advent Health
Orlando, Florida, United States
Orlando Health
Orlando, Florida, United States
Health Synergy Clinical Research
West Palm Beach, Florida, United States
NorthShore University Health System
Evanston, Illinois, United States
Heartland Medical Research, Inc.
Clive, Iowa, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
John Hopkins
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Cooper Health System
Camden, New Jersey, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
The Ohio State University- Wexner Medical Center
Columbus, Ohio, United States
Velocity Clinical Research - Austin
Austin, Texas, United States
Dell Medical School
Austin, Texas, United States
IMA Clinical Research - Austin
Austin, Texas, United States
The University of Texas Health Science Center at Houston
Bellaire, Texas, United States
Velocity Clinical Research, Dallas
Dallas, Texas, United States
Southwest Medical Center
Dallas, Texas, United States
University of Texas Southwestern Medical School - William P. Clements Jr. University Hospital
Dallas, Texas, United States
Epic Medical Research
DeSoto, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
Juno Research, LLC
Houston, Texas, United States
Texas Diabetes & Endocrinology, P.A.
Round Rock, Texas, United States
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, United States
IMA Clinical Research - San Antonio
San Antonio, Texas, United States
Mt. Olympus Medical Research
Sugar Land, Texas, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
The BMI Clinic
Double Bay, New South Wales, Australia
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Eastern Health - Box Hill Hospital
Box Hill, Victoria, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Baker Heart and Diabetes Institute
Melbourne, Victoria, Australia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
898
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.