Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625138
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Trial of Latex Vs Non-latex Hemorrhoid Banding
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Single-blinded Randomized Trial of Latex Vs Non-latex Hemorrhoid Banding
Status:
ACTIVE_NOT_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:
NO-Tex
Brief Summary:
This study will involve the recruitment of adult patients with hemorrhoids for whom rubber band ligation is the recommended treatment Patients will be randomized to receive banding with a latex band or non-latex band Our goal will be to measure the performance of latex bands vs non-latex bands
Detailed Description:
This study will involve the recruitment of adult patients with symptomatic grade 2-3 internal hemorrhoids for whom rubber band ligation is the recommended treatment Patients will be randomized to receive banding with a latex band or non-latex band Our hypothesis is that non-latex hemorrhoidal bands are non-inferior to latex bands for the treatment of grade 2-3 internal hemorrhoids
The secondary objective of the study is to compare banding-related adverse effects including pain bleeding and complications assessed both immediately and within 3 weeks following each hemorrhoidal banding
The secondary objective of the study is to compare banding-related adverse effects including pain bleeding and complications assessed both immediately and within 3 weeks following each hemorrhoidal banding
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