An interventional study of Endoscopic gastroplasty in Obesity, sponsored by Kaiser Clinic and Hospital. Completed at 3 sites in Brazil. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-08-17.
Sponsored by Kaiser Clinic and Hospital · Not applicable, Interventional, and Treatment
Obesity is a chronic disease that has grown to epidemic characteristics in Brazil and around the world in recent years. Treatment for patients with class III or class II obesity with comorbidities is already well established, with bariatric surgery being the best option. However, there is no consensus as to the best treatment for cases of class I and class II obesity without comorbidities. The objective of this research will be to make a gastric tube similar to that obtained in surgical gastroplication however it will be created using intragastric endoscopic sutures. The procedures will be performed at the Endoscopy Service of the Mario Covas Hospital in São Paulo, SP. Data collection will be performed at the same location.
The objective of this research will be to make a gastric tube similar to that obtained in surgical gastroplication however it will be created using intragastric endoscopic sutures. The secondary objective will be to correlate demographic, endoscopic and laboratory data with the results of this procedure.
Patients and Methods: Patients with class I obesity with or without comorbidities and patients with class II obesity without comorbidities, irrespective of gender and ethnic background, from the state of São Paulo and other states of the country will be submitted to vertical endoscopic gastroplasty. The procedures will be performed at the Endoscopy Service of the Mario Covas Hospital in São Paulo, SP. Data collection will be performed at the same location.
Information will be obtained during the outpatient follow-up at the Hospital Mario Covas including demographic (gender, age), clinical (height, weight, time after procedure, systemic arterial hypertension, diabetes, dyslipidemia, smoking, alcohol consumption) and operative data (complications).
Preparation for the procedure: All the exams will be performed at the Hospital Mario Covas after the patients have fasted for at least 8 hours. The procedure will begin with the patient in left lateral decubitus under general anesthesia performed by an anesthesiologist. Endoscopic sutures will be performed using 2-0 prolene thread until a tubular-shaped stomach is formed similar to a vertical gastrectomy.
Recovery after the procedure: After the procedure and recovery from anesthesia, all patients will be discharged but only together with a companion. All patients will receive guidance and will remain in touch with a physician to report any adverse signs or symptoms.
Outcomes Primary outcome: To confirm the efficacy of endoscopic sutures in the primary treatment of obesity.
Secondary outcome: To evaluate the use of the endoscopic sutures in relation to demographic data.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 30 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Kaiser Clinic and Hospital is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
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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.
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.
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.
Make a gastric tube similar to that obtained in surgical gastroplication however it will be created using intragastric endoscopic sutures.
Procedure: Endoscopic gastroplasty
Vertical endoscopic gastroplasty
Weight loss
Weight in Kg and Body Mass Index (BMI) in kilograms by meters squared
Time frame: 48 weeks
Blood count
Measured in cmm
Time frame: 48 weeks
Hb1AC
Measured in percentage
Time frame: 48 weeks
Cholesterol
Measured in mg/dL
Time frame: 48 weeks
Fasting blood glucose
Measured in mg/dL
Time frame: 48 weeks
Procedural complications
Complications related to the procedure, either at the time of the procedure (bleeding, perforation and suture rupture) or in the postoperative period, performing an endoscopy at 6 months and 1 year to evaluate the suture line.
Time frame: At the time of procedure and at 6 months and 1 year follow-up period
Plan to share: Yes
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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