Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-26 @ 2:56 PM
Study NCT ID:
NCT04007692
Status:
TERMINATED
Last Update Posted:
2024-09-19
First Post:
2019-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Endoscopic Suturing Pattern for Esophageal Stent Fixation
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Suturing Pattern for Endolumenal Stenting Procedures
Status:
TERMINATED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Accrual difficulties:
This trial was initiated prior to COVID-19 and interrupted by the pandemic for a significant length of time.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Researchers are trying to determine which suturing pattern for esophageal stent placement is more effective in a randomized fashion as currently what suturing pattern to use is an arbitrary decision.
Detailed Description:
The participants who are receiving esophageal stent placement will be prospectively randomized to receive two suturing patterns (simple interrupted pattern and triangular pattern) for endoscopic esophageal stent fixation. We will investigate rate of the stent migration at 3-4 weeks by endoscopy after the stent placement as part of routine clinical care. Data of the duration of endoscopic suturing, adverse events, details of the stent used, indication for use will also be collected.
Study Oversight
Has Oversight DMC:
False
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?: