Evaluation of safety and efficacy of a new minimally invasive procedure for weight reduction through gastric fundus ischemia.

Not Applicable

• Conditions: Obesity; non-insulin-dependent diabetes mellitus; essential (primary) hypertension; metabolic syndrome.; E66.0; C18.452.394.968.500.570

• Registration Number: RBR-78c25h
• Lead Sponsor: Hospital Federal de Bonsucesso

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Ten patients, females, over the age of 18 and under 50 years old; with a diagnosis of obesity grades 1 and 2 and Metabolic Syndrome .

Exclusion Criteria

Individuals weighing more than 180 kg; pregnant or wishing to become pregnant within the next six months; with history of gastric surgery, alcoholism or previous drug abuse; with coagulation disorder and presence of advanced heart, lung or liver disease.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical safety assessment of bariatric embolization through the absence of severe complications that require rehospitalization after discharge or new surgical interventions to treat it.

Secondary Outcome Measures

Name	Time	Method
Evaluate the change in ghrelin levels in pg / ml after the procedure until the sixth month;;Evaluation of weight loss in kg over the six months after the intervention;;Evaluation of the evolution of gastric symptoms before and up to six months after the intervention through the PADYQ questionnaire;;Evaluation of the evolution of binge eating symptoms before and up to six months after intervention through the periodic eating binge scale;;Evaluation of the evolution of the quality of life before and until six months after the intervention through the WHOQOL-BREF questionnaire;;Evaluation of changes in body composition 6 months after the procedure through bioimpedance;;Evaluation of changes in blood pressure levels in mmHg, serum lipids in mg / dL and fasting glucose after the intervention for a period of six months.