Ignite Creation Date:
2024-05-06 @ 2:53 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04457193
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-13
First Post:
2020-06-30
Brief Title:
Outcomes After Transoral Incisionless Fundoplication TIF Following Successful Endoscopic Ablation for Barretts Esophagus
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Outcomes After Transoral Incisionless Fundoplication TIF Following Successful Endoscopic Ablation for Barretts Esophagus A Pilot Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
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:
None
Brief Summary:
Barretts esophagus BE is a precancerous lesion characterized by the replacement of the normal stratified squamous epithelium of the distal esophagus by intestinal metaplasia IM Non-dysplastic BE may progress to low-grade dysplasia LGD to high-grade dysplasia HGD and esophageal adenocarcinoma EAC Endoscopic ablation is safe and effective for complete eradication of BE However recurrence is common Cumulative incidence rate of BE recurrence is up to 30 in the third year Thus achieving complete eradication of IM patients should undergo surveillance indefinitely with serial endoscopy to assess for recurrence of BE In addition BE patients have been committed to life-long proton pump inhibitor PPI therapy but increasing concerns about adverse effects has led to alternative therapies Studies have showed that laparoscopic Nissen fundoplication may decrease recurrence of BE after endoscopic ablation Transoral Incisionless Fundoplication TIF is an endoscopic procedure that mechanically creates fundoplication similar to traditional operative Nissen fundoplication The role of TIF in patients with BE whom underwent successful endoscopic ablation has not been fully investigated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None