An interventional study of Device arm and Sham arm in Obesity, sponsored by Kaiser Clinic and Hospital. Completed at 2 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 proportions in Brazil and throughout the world in recent years. Bariatric surgery has been the most effective method for the treatment and prophylaxis of complications caused by morbid obesity, thereby increasing the longevity and quality of life of patients. The treatment of patients with Class III obesity or higher or Class II with comorbidities is already well established with bariatric surgery being the best option. However, there is no consensus as to the best treatment in cases of Class I or II obesity without comorbidities. The objective of this research will be to make a gastric tube similar to that obtained by surgical gastroplication but using endoscopic intragastric sutures.
The primary objective of this research will be to make a gastric tube similar to that obtained by surgical gastroplication but using endoscopic intragastric sutures. The secondary objective will be to correlate demographic, endoscopic and laboratory data with the outcomes.
This study will be carried out in two institutions. The Kaiser Clinic and Day Hospital and the Faculty of Medicine of ABC. Sixty patients will be randomly selected for treatment by Endospore Endoscopy (ESG) or as controls (only the endoscopist will know which group each patient belongs to). The draw will take place only after upper endoscopy has been carried out to avoid possible contraindications for the procedure due to injuries. Once the criteria for endoscopic evaluation have been met, randomization will be carried out in loco with the patient still sedated. Gastric Endo Sutures will be performed when the patient is randomized for Group I; Group II will be the control group. All patients will be followed up for two years by a multidisciplinary team (endoscopist, surgeon, nutritionist and psychologist). The data will be obtained during the outpatient follow-up at the Hospital Mario Covas and will include demographic (gender, age), clinical (height, weight, BMI, time after procedure, hypertension, diabetes, dyslipidemia, smoking, alcoholism) and operative data (complications).
Preparation to perform the examination/procedure: All exams will be performed with the patients within eight hours. The procedure will begin with the patient in left lateral decubitus position and under general anesthesia performed by an anesthesiologist. Endoscopic suturing will be performed with 2-0 prolene stitches until a tubular-shaped stomach is formed similar to vertical gastrectomy.
Recovery after the procedure: After this procedure and recovery from the anesthesia, all patients will only be discharged in the company of a companion. All patients will be counseled to enter in touch with the physician to report any signs or symptoms.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 60 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.
Gastric endosuturing will be performed until the entire gastric body is sutured in the form of a tube.
Procedure: Device arm
Group II is a control group (only the endoscopist will know which group each patient belongs to)
Procedure: Sham arm
Make a gastric tube (endoscopic sleeve gastroplasty) using the Apollo Overstitch suturing device through endoscopy.
Group II will be conducted identically to Group I except for the procedure itself, and only the endoscopist, that is the researcher, will be aware of which group each patient belongs to.
Weight loss
weight in kg
Time frame: outcome will be evaluated for 2 years
Weight maintenance
weight in kg
Time frame: 2 years
Surgical related complications
Time frame: 2 years
Comorbidities
Time frame: 2 years
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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