Obesity
Conditions
Keywords
Obesity, Endoscopic sleeve gastroplasty, Weight loss
Brief summary
Emerging endoscopic techniques are minimally invasive and can mimic the anatomic alterations achieved by surgical sleeve gastrectomy. The study hypothesis is if endoscopic sleeve gastroplasty is effective and useful in the treatment of patients with obesity
Detailed description
The endoscopic sleeve gastroplasty method to perform endoluminal gastric reduction were by a cap-based flexible endoscopic suturing system. Post procedure care includes close follow-up by a nutritionist and a psychologist weekly.The outcome assessment included: change in body weight, percentage of loss of excess body weight and adverse effects
Interventions
PROCEDUREEndoscopic sleeve gastroplasty
To perform endoluminal gastric volume reduction by the Endoscopic sleeve gastroplasty
Sponsors
Grupo Hospital de Madrid
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Obesity Willingness and ability of patients to be treated by a multidisciplinary team for at least 1 year -
Exclusion criteria
Prior endoscopy discarded patients with gastric findings (potentially bleeding lesions and neoformative findings ) Coagulopathy Psychiatric disorders \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight | One year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | One year | Any complications following the intervention like abdominal pain or bleeding |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of excess weight loss | One year | Percentage of excess weight loss defined as the percentage of weight loss in relation with initial weight minus weight at BMI of 25 kg/m2 |
Countries
Spain
Contacts
Primary ContactGONTRAND LOPEZ-NAVA, MD
Backup ContactINMACULADA BAUTISTA-CASTAÑO, MD, PHD
Outcome results
None listed