Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657339
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
National Registry of Obesity Treatment by Endosleeve
Sponsor:
None
Organization:
None
Study Overview
Official Title:
National Registry of Obesity Treatment by Endosleeve
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Obesity and overweight have emerged as public health problems of a pandemic nature significantly reducing the life expectancy of those affected Obesity has a considerable medico-economic impact linked to the treatments it requires and its comorbidities Currently the prevention of obesity in our Western societies is not effective enough as the prevalence and incidence of obesity and overweight continue to rise worldwide In France the therapeutic management of this condition is governed by the HAS and is summarized as a surgical approach for type 2 obesity with comorbidity or type 3 obesity with three authorized methods that have shown sufficient evidence gastric banding sleeve gastrectomy or longitudinal sleeve gastrectomy and Roux-en-Y gastric bypass
With the advent of organ-preserving interventional endoscopy the systematic use of these surgical methods although effective for total weight loss and excess weight loss raises questions Indeed these new therapeutic endoscopic approaches which are less invasive less costly and respectful of anatomy currently show convincing cohort results in the short term 12 to 24 months and require confirmation of their effectiveness and safety in the long term 5 years so that they can become first-line therapeutic methods in the near future At the request of the HAS in its self-referral of 2020 and then in 2022 this prospective registry aims to confirm the effectiveness and safety of the endosleeve or endoscopic sleeve in the long-term therapeutic management of obesity within the framework of everyday practice in national reference centers for obesity treatment
With the advent of organ-preserving interventional endoscopy the systematic use of these surgical methods although effective for total weight loss and excess weight loss raises questions Indeed these new therapeutic endoscopic approaches which are less invasive less costly and respectful of anatomy currently show convincing cohort results in the short term 12 to 24 months and require confirmation of their effectiveness and safety in the long term 5 years so that they can become first-line therapeutic methods in the near future At the request of the HAS in its self-referral of 2020 and then in 2022 this prospective registry aims to confirm the effectiveness and safety of the endosleeve or endoscopic sleeve in the long-term therapeutic management of obesity within the framework of everyday practice in national reference centers for obesity treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None