Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic sleeve gastroplasty | Experimental | The intervention is an endoscopic procedure: to perform endoscopic sleeve gastroplasty we used a cap-based flexible endoscopic suturing system (OverStitchâ„¢, Apollo, Inc. Austin, Texas) mounted on a double-channel endoscope (GIF-2T160; Olympus Medical Systems Corporation, Tokyo, Japan) to achieve full-thickness, running sutures through the gastric wall from antrum to fundus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic sleeve gastroplasty | Procedure | To perform endoluminal gastric volume reduction by the Endoscopic sleeve gastroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Any complications following the intervention like abdominal pain or bleeding | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of excess weight loss | 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 | One year |
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
-
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GONTRAND LOPEZ-NAVA, MD | Contact | +34917567800 | gontrandlopeznava@gmail.com | |
| INMACULADA BAUTISTA-CASTAÑO, MD, PHD | Contact | +34917567800 | inmaculadabautista60@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| GONTRAND LOPEZ-NAVA, MD | HOSPITAL UNIVERSITARIO SANCHINARRO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Sanchinarro | Recruiting | Madrid | Madrid | 28050 | Spain |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |