Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03493620
Other study ID # ApolloSham
Secondary ID
Status Recruiting
Phase N/A
First received March 14, 2018
Last updated April 3, 2018
Start date January 8, 2018
Est. completion date August 1, 2020

Study information

Verified date April 2018
Source Kaiser Clinic and Hospital
Contact Luiz Gustavo de Quadros, MD
Phone 5517981388737
Email gustavo_quadros@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 1, 2020
Est. primary completion date August 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Aged over 18 years,

- BMI > 30 and < 36 kg/m2, with or without comorbidities,

- BMI > 36 and < 40 without comorbidities

Exclusion Criteria:

- Previous gastric surgery

- Taking anticoagulant drugs

- Psychiatric disorders

- Severe esophagitis

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Device arm
Make a gastric tube (endoscopic sleeve gastroplasty) using the Apollo Overstitch suturing device through endoscopy.
Sham arm
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.

Locations

Country Name City State
Brazil Faculty of Medicine of ABC Santo André SP
Brazil Kaiser Clinic and Day Hospital São José Do Rio Preto SP

Sponsors (1)

Lead Sponsor Collaborator
Kaiser Clinic and Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight loss weight in kg outcome will be evaluated for 2 years
Secondary Weight maintenance weight in kg 2 years
Secondary Surgical related complications 2 years
Secondary Comorbidities 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Recruiting NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT03255005 - Endomina Controlled Study N/A
Enrolling by invitation NCT03063606 - Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment Phase 2/Phase 3
Completed NCT03317587 - Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise (INSPIRE) N/A
Terminated NCT03299881 - Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss N/A
Not yet recruiting NCT03569774 - Individualized vs Low PEEP in One Lung Ventilation N/A
Active, not recruiting NCT03610958 - Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss. N/A
Completed NCT02235961 - Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects Phase 1
Completed NCT03195712 - Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers N/A
Recruiting NCT00341406 - Fat Cell Size in Insulin Resistance
Not yet recruiting NCT03538236 - Intragastric Balloon With Lifestyle Intervention vs. Lifestyle Intervention in Obese Patients With NASH N/A
Not yet recruiting NCT03470272 - Effects of Red Light LED Therapy on Body Contouring N/A
Recruiting NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Active, not recruiting NCT02918279 - Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity Phase 3
Completed NCT00494767 - Investigation Of Weight Loss And Body Composition Changes After Dosing With Either Placebo Or One Of Two Active Drugs Phase 1
Recruiting NCT03338296 - Study to Evaluate the Efficacy and Safety of Belviq XR® in Conjunction With Lifestyle Modification for Weight Loss in Obese Adolescents, Age 12 to 17 Years Phase 4
Recruiting NCT03277040 - Diet, Eating, and Lifestyle Improvement for Valued Employees and Their Relatives N/A
Active, not recruiting NCT03345368 - Effect of rTMS in Combination With a Low-carb Diet in Patients With Obesity N/A