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Efficacy and Results of Endoscopic Gastroplasty Using Overstitch in Patients With Class I and II Obesity

NCT03493620 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-08-17

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Device arm

Make a gastric tube (endoscopic sleeve gastroplasty) using the Apollo Overstitch suturing device through endoscopy.

PROCEDURE

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.

Sponsors & Collaborators

  • Kaiser Clinic and Hospital

    lead OTHER

Principal Investigators

  • Luiz Gustavo de Quadros, MD · Kaiser Clinica and Day Hospital

  • Eduardo Grecco, MD · ABC Medical School

  • Manoel Galvao Neto, MD · ABC Medical School

  • Thiago Ferreira de Souza, PhD · ABC Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2019-08-01
Completion
2020-08-01

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03493620 on ClinicalTrials.gov