Ignite Creation Date:
2024-05-06 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03554902
Status:
RECRUITING
Last Update Posted:
2024-01-08
First Post:
2018-05-16
Brief Title:
Endoscopic Gastric Tubulization
Sponsor:
IHU Strasbourg
Organization:
IHU Strasbourg
Study Overview
Official Title:
Endoscopic Gastric Tubulization
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Endosleeve
Brief Summary:
Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil Strasbourg France to adult patients with morbid obesity The procedure is performed using the CE marked endoscopic suture device Overstitch Apollo Endosurgery Austin Tx USA It is standard practice since October 2016
The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization from last visit before procedure to 2 years after procedure These data are usually collected during medical consultations and will enable the evaluation of weight loss quality of life and comorbidities improvement reproducibility and durability of the technique
The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization from last visit before procedure to 2 years after procedure These data are usually collected during medical consultations and will enable the evaluation of weight loss quality of life and comorbidities improvement reproducibility and durability of the technique
Detailed Description:
Gastric restriction is one of the fundamental principles of gastric bypass and gastric banding Despite its advantages long term weight loss comorbidities related to obesity improvement bariatric surgery is risky In fact complications putting the patient into a life-threatening condition can occur Endoscopic approaches are similar to current surgical methods but less invasive safer and allow ambulatory care
Nowadays practitioners have the possibility to reduce stomach size by merging tissues through an endoscopic endoluminal suture approach without any incision This leads to similar results gastric restriction weight loss quality of life and comorbidities improvement compared with standard surgical procedure while reducing the risk of complications
One of the major benefit of this technique is its reversibility A new surgical or endoscopic procedure is possible at a later stage
Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil Strasbourg France to adult patients with morbid obesity The procedure is performed using the CE marked endoscopic suture device Overstitch Apollo Endosurgery Austin Tx USA It is standard practice since October 2016
The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization from last visit before procedure to 2 years after procedure These data are usually collected during medical consultations and will enable the evaluation of weight loss quality of life and comorbidities improvement reproducibility and durability of the technique
Nowadays practitioners have the possibility to reduce stomach size by merging tissues through an endoscopic endoluminal suture approach without any incision This leads to similar results gastric restriction weight loss quality of life and comorbidities improvement compared with standard surgical procedure while reducing the risk of complications
One of the major benefit of this technique is its reversibility A new surgical or endoscopic procedure is possible at a later stage
Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil Strasbourg France to adult patients with morbid obesity The procedure is performed using the CE marked endoscopic suture device Overstitch Apollo Endosurgery Austin Tx USA It is standard practice since October 2016
The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization from last visit before procedure to 2 years after procedure These data are usually collected during medical consultations and will enable the evaluation of weight loss quality of life and comorbidities improvement reproducibility and durability of the technique
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-A03599-44 | OTHER | ANSM France | None |