Evaluating the Efficacy and Results of Endoscopic Gastroplasty Performed Using Overstitch in Patients With Obesity.
Prospective Multicenter Study to Evaluate the Efficacy and Results of Endoscopic Gastroplasty Performed Using Overstitch in Patients With Class I and II Obesity.
1 other identifier
interventional
30
1 country
3
Brief Summary
Obesity is a chronic disease that has grown to epidemic characteristics in Brazil and around the world in recent years. Treatment for patients with class III or class II obesity with comorbidities is already well established, with bariatric surgery being the best option. However, there is no consensus as to the best treatment for cases of class I and class II obesity without comorbidities. The objective of this research will be to make a gastric tube similar to that obtained in surgical gastroplication however it will be created using intragastric endoscopic sutures. The procedures will be performed at the Endoscopy Service of the Mario Covas Hospital in São Paulo, SP. Data collection will be performed at the same location.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Jun 2017
Typical duration for not_applicable obesity
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2017
CompletedFirst Posted
Study publicly available on registry
March 23, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedAugust 17, 2022
August 1, 2022
7 months
March 6, 2017
August 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Weight loss
Weight in Kg and Body Mass Index (BMI) in kilograms by meters squared
48 weeks
Secondary Outcomes (5)
Blood count
48 weeks
Hb1AC
48 weeks
Cholesterol
48 weeks
Fasting blood glucose
48 weeks
Procedural complications
At the time of procedure and at 6 months and 1 year follow-up period
Study Arms (1)
Endoscopic gastroplasty
EXPERIMENTALMake a gastric tube similar to that obtained in surgical gastroplication however it will be created using intragastric endoscopic sutures.
Interventions
Eligibility Criteria
You may qualify if:
- BMI \> 30 and \< 36 with or without comorbidities
- BMI \> 36 and \< 40 without comorbidities
You may not qualify if:
- Prior gastric surgery
- Use of anticoagulants
- Psychiatric disorders
- Severe esophagitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Mario Covas Hospital
Santo André, São Paulo, 09190-615, Brazil
Kaiser Day hospital
São José do Rio Preto, São Paulo, Brazil
9 de Julho Hospital
São Paulo, São Paulo, 01409-002, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luiz Guatavo de Quadros, MD
Kaiser Clinica and Day Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2017
First Posted
March 23, 2017
Study Start
June 1, 2017
Primary Completion
December 31, 2017
Study Completion
December 31, 2020
Last Updated
August 17, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share