An interventional study of ESG with OverStitch in Type 2 Diabetes Mellitus (T2D) and Obesity (BMI>30), sponsored by Boston Scientific Corporation. Not yet recruiting. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to determine whether Endoscopic Sleeve Gastroplasty (ESG)-induced weight loss can improve glycemic outcomes and alter the trajectory toward insulin dependence in adults with obesity and inadequately controlled Type 2 Diabetes (T2D) despite guideline-directed therapy, including Glucagon-Like Peptide-1 Receptor Agonists (GLP-1RA)-based agents.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Boston Scientific Corporation is the lead sponsor of 528 studies on the registry; 40 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: ESG with OverStitch
Endoscopic Sleeve Gastroplasty (ESG) with OverStitch Endoscopic Suturing System.
Serious Adverse Events
Serious Adverse Events related to the study procedure and/or study device defined as Grade III or greater according to Clavien-Dindo Classification
Time frame: Through study completion, 12 months post procedure
Average Change in HbA1c
Mean change in HbA1c from baseline to 1-year. If rescue treatment is initiated, the last HbA1c value before initiation of rescue treatment is used for assessment of the primary effectiveness endpoint.
Time frame: 12 months post procedure
Proportion of Subjects Achieving HbA1c < 7%
Proportion of subjects achieving HbA1c \< 7% without initiating rescue treatment at 1-year
Time frame: 12 months post procedure
Weight Loss
Total Body Weight Loss (TBWL) % and Excess Weight Loss (EWL) % at each visit
Time frame: 1, 3, 6, 9, and 12 months post procedure
Proportion of Subjects with a Total Body Weight Loss ≥ 10%
Proportion of subjects with a TBWL ≥ 10% at each visit
Time frame: 1, 3, 6, 9, and 12 months post procedure
Proportion of Subjects Achieving HbA1c < 6.5%
Proportion of subjects achieving HbA1c \< 6.5% without initiating rescue treatment at 1-year
Time frame: 12 months post procedure
Proportion of Subjects Achieving TBWL ≥ 10% AND HbA1c < 6.5%
Proportion of subjects with a TBWL ≥ 10% AND a HbA1c \< 6.5% without initiating rescue treatment at 1-year
Time frame: 12 months post procedure
Proportion of Subjects Initiating Rescue Treatment
Proportion of subjects initiating rescue treatment at any time during the study follow-up period
Time frame: Through study completion, 12 months post procedure
Proportion of Subjects Meeting Rescue Criteria
Proportion of subjects meeting rescue criteria at any time during the study follow-up period
Time frame: Through study completion, 12 months post procedure
Proportion of Subjects with Improvement in Comorbidities
Proportion of subjects with improvement in each specific obesity-related comorbidity, as applicable, from baseline to 1-year: Hypertension, Dyslipidemia, Obstructive sleep apnea, Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Time frame: 12 months post procedure
Change in Vitals
Change in vitals from baseline to 6-months and from baseline to 1-year: Systolic blood pressure, Diastolic blood pressure
Time frame: 6 and 12 months post procedure
Change in Blood Laboratory Tests
Change in blood laboratory tests from baseline to 6-months and from baseline to 1-year: fasting plasma glucose, estimated glomerular filtration rate (eGFR), aspartate aminotransferase (AST), alanine aminotransferase (ALT,) low-density lipoprotein cholesterol (LDL-C), Triglycerides
Time frame: 6 and 12 months post procedure
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Change in HOMA-IR from baseline to 6-months and from baseline to 1-year
Time frame: 6 and 12 months post procedure
Change in Fibrosis-4 (FIB-4)
Change in FIB-4 from baseline to 6-months and from baseline to 1-year
Time frame: 6 and 12 months post procedure
Change in Nonalcoholic Fatty Liver Disease (NAFLD) Fibrosis Score
Change in NAFLD Fibrosis Score (NFS) from baseline to 6-months and from baseline to 1-year
Time frame: 6 and 12 months post procedure
Change in Diabetes Treatment Satisfaction
Change in diabetes treatment satisfaction, as assessed by Diabetes Treatment Satisfaction Questionnaire - status (DTSQs), from baseline to 1-year and Diabetes Treatment Satisfaction Questionnaire - change (DTSQc) at 1-year; Positive score indicates an improvement in satisfaction, or a reduction in the frequency of hyper/hypoglycemia. Negative score indicates a deterioration in satisfaction, or an increase in the frequency of hyper/hypoglycemia. Zero indicates no change in satisfaction or symptoms.
Time frame: 12 months post procedure
Change in Diabetes Self-Care Activity
Change in diabetes self-care activity, as assessed by Summary of Diabetes Self-Care Activity (SDSCA), from baseline to 6-months and from baseline to 1-year; Higher scores indicate better compliance with diabetic self-care recommendations. Lower scores point to areas where the patient may be struggling or may need additional education and support.
Time frame: 6 and 12 months post procedure
Change in Quality of Life
Change in quality of life, as assessed by 36-Item Short Form Health Survey (SF-36) domain scores and Physical and Mental Component Summaries (PCS and MCS), from baseline to 1-year; Higher scores indicate a better, higher quality of life and fewer health-related limitations.
Time frame: 12 months post procedure
Adverse Events
Adverse events associated with study procedure and/or study device
Time frame: Through study completion, 12 months post procedure
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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