Clinical trial

Endoscopic Sleeve Gastroplasty Plus Duodenal pulsENDO for Obese T2DM

Recruiting now · Not applicable · 1 countries · Registry ID NCT07660445

Recruiting nowNot applicableInterventional

What this study is about

This study is designed to evaluate the efficacy, safety, and mechanisms of combining ESG and pulsENDO procedure in obese patients with T2DM

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity Type 2 Diabetes Mellitus

Full registry criteria

Inclusion Criteria: * BMI \>/= 27kg/m2 * Known T2DM * Individualized Metabolic Surgery (IMS) score 25-115 * HbA1c \<11% (subjects on oral glucose lowering drug(s) or HbA1c \<8% (subjects on insulin) Exclusion Criteria: * Previous treatment with ReCET, ESG or similar procedure * Previous GI surgery that could preclude the ability to perform ReCET or ESG, or acute gastric and duodenal pathology that increased the risk of ReCET or ESG * Type 1 DM, DM secondary to specific disease or having any history of ketoacidosis * Fasting C-peptide level \<0.5ug/L * Any inflammatory disease of the gastrointestinal tract such as Crohn's disease * Abnormal pathologies or conditions of the gastrointestinal tract, including duodenal polyps, ulcers or upper gastrointestinal bleeding conditions within 3 months of study * Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter or known coagulopathy * Currently taking prescription antithrombotic therapy (e.g., anticoagulant agent) within 10 days prior to study and/or there is a need or expected need to use during the study period * Currently taking medications known to cause significant weight gain or weight loss (e.g. chemotherapeutics) * Patients who have used non-steroidal analgesics and anti-inflammatory drugs (NSAID) and corticosteroids in the past 1 month * Underlying uncontrolled endocrine problem that leads to obesity, including and not limited to hypothyroidism, Cushing syndrome and eating disorder. * Patients with contra-indications to endoscopy * Patients with cirrhosis due to causes other than MASLD * Malignancy * Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma) * Pregnant or breast feeding * ASA grade IV \& V * Mental or psychiatric disorder; Drug or alcohol addiction * Other cases deemed by the examining physician as unsuitable for safe treatment * Refusal to participate

Treatments and study arms

Endoscopic sleeve gastroplasty plus duodenal recellularization via electroporation therapy (pulsENDO)

Procedure

First part - pulsENDO procedure : The pulsENDO procedure utilizes the pulsENDO catheter to deliver non-thermal pulsed electric field to the 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 under endoscopic visualisation, starting from D4 and repeated proximally. Approximately 10-18 cm of axial length of the duodenum is treated. Second part - Endoscopic sleeve gastroplasty : ESG is performed using an endoscopic suturing device (Overstitch, BSC) to reduce the stomach volume through the creation of a restrictive endoscopic sleeve. This is accomplished with around 4-7 permanent full thickness sutures over greater curve stomach in a running plication extending from the angular incisura and continuing proximally with fundal sparing.

Primary outcomes

Change in Diabetic medications12 months post-procedure

Changes of glucose lower drugs/ insulin dosage

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Prince of Wales Hospital, the Chinese University of Hong Kong🇭🇰 Shatin, Hong Kong
Stephen Ng, FRCSEd(Gen)Contact
Ivy PoonContact
Philip Chiu, MDSub Investigator