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

NCT03493620 | Completed

• 1 other identifier: ApolloSham
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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

Obesity

Outcome Measures

Primary Outcomes (1)

• Weight loss

  weight in kg

  outcome will be evaluated for 2 years

Secondary Outcomes (3)

• Weight maintenance

  2 years

• Surgical related complications

  2 years

• Comorbidities

  2 years

Study Arms (2)

Device arm

EXPERIMENTAL

Gastric endosuturing will be performed until the entire gastric body is sutured in the form of a tube.

Procedure: Device arm

Sham arm

SHAM COMPARATOR

Group II is a control group (only the endoscopist will know which group each patient belongs to)

Procedure: Sham arm

Interventions

Device arm PROCEDURE

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

Device arm

Sham arm PROCEDURE

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.

Sham arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged over 18 years,
• BMI \> 30 and \< 36 kg/m2, with or without comorbidities,
• BMI \> 36 and \< 40 without comorbidities

You may not qualify if:

• Previous gastric surgery
• Taking anticoagulant drugs
• Psychiatric disorders
• Severe esophagitis

Sponsors & Collaborators

• Kaiser Clinic and Hospital: lead

Study Sites (2)

Faculty of Medicine of ABC

Santo André, São Paulo, Brazil

Location

Kaiser Clinic and Day Hospital

São José do Rio Preto, São Paulo, Brazil

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luiz Gustavo de Quadros, MD

  Kaiser Clinica and Day Hospital

  PRINCIPAL INVESTIGATOR

• Eduardo Grecco, MD

  ABC Medical School

  PRINCIPAL INVESTIGATOR

• Manoel Galvao Neto, MD

  ABC Medical School

  PRINCIPAL INVESTIGATOR

• Thiago Ferreira de Souza, PhD

  ABC Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: April 10, 2018
• Study Start: January 8, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2020
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

BR (2)