Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04867590
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2021-04-27
Brief Title:
A Study Comparing the Effectiveness of EndoRotor Versus Radiofrequency in Treating Barretts Esophagus
Sponsor:
University Hospital Angers
Organization:
University Hospital Angers
Study Overview
Official Title:
A Controlled Randomised Multicenter Study Comparing the Effectiveness of EndoRotor New Treatment Technique Versus Radiofrequency Reference Technique in Treating Barretts Esophagus Complicated by Dysplasia
Status:
RECRUITING
Status Verified Date:
2024-04
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:
ENDOBARRETT
Brief Summary:
Barrett Esophagus is a common pathology with an estimated prevalence of 16 at risk of progression to precancerous mucosa low to high grade dysplasia The incidence of adenocarcinoma on BE is 05 per year In the event of dysplasia or cancer in situ it is currently recommended at international and particularly European level to eradicate BE The treatment techniques used to date carry out thermal destruction of the BE in particular by radiofrequency Eradication of dysplasia is achieved in 81 to 100 and disappearance of BE in 73 to 87 of cases It requires an average of 3 destruction sessions RF does not allow histological analysis after destruction of BE but the risk of progression to neoplasia is estimated at 781000 persons per year This risk could be due to the presence of glands buried in the esophageal mucosa Indeed these glands are not destroyed by thermal ablation methods and remain invisible during endoscopic controls
A new treatment technique using the Endorotor system allows mechanical resection of the entire mucosa in one session of treatment In addition the cost of these thermal destruction techniques currently limits their wider diffusion It is therefore legitimate to propose a less expensive and probably more effective alternative technique
A new treatment technique using the Endorotor system allows mechanical resection of the entire mucosa in one session of treatment In addition the cost of these thermal destruction techniques currently limits their wider diffusion It is therefore legitimate to propose a less expensive and probably more effective alternative technique
Detailed Description:
None
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