Health TrialsbyHealthPanel

Endoscopic Sleeve Gastroplasty Plus Duodenal pulsENDO for Obese T2DM

ConditionObesity Type 2 Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorChinese University of Hong Kong

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

    Procedure/Surgery

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: ESG plus duodenal pulsENDOExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Diabetic medications

Changes of glucose lower drugs/ insulin dosage

Time frame
12 months post-procedure

Secondary outcomes

1

Total body weight loss (%TBWL)

Percent total body weight loss (%TBWL) from baseline to Month 24

Time frame
24 months post-procedure
2

Incidence of adverse events

Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE)

Time frame
within 30 days post-procedure
3

Body fat percentage

Changes in body fat percentage - measured by bioelectrical impedance analysis from baseline to Month 24

Time frame
24 months post-procedure
4

Change in Quality of Life

measured by 36-Item Short Form Survey (SF-36) questionnaire - (score 0:worst - 100:best) from baseline to Month 24

Time frame
24 months post-procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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