Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-02-25 @ 9:49 PM
Study NCT ID:
NCT02703558
Status:
WITHDRAWN
Last Update Posted:
2018-01-12
First Post:
2016-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Fluorescein Use During Cystoscopy
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Evaluation of Fluorescein Use During Cystoscopy, a Randomized Control Trial
Status:
WITHDRAWN
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Limited interest from colleagues/time constraints
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EFLUC
Brief Summary:
This study is a prospective randomized controlled study. Female patients over 18 years of age, who present for treatment of pelvic organ prolapse and/or stress urinary incontinence at the Pelvic Floor Center at the Johns Hopkins Bayview Medical Center, and who consent to undergo a urogynecologic surgical procedure, will be considered for inclusion in the study. Their histories will be reviewed by their attending surgeon and if they meet inclusion and exclusion criteria, they will be recruited for participation. The primary investigator and co-investigators (attending physician, fellows) will determine patient eligibility. Regarding privacy issues, the patients will be consented for both the procedure and for the study with careful attention made to emphasize patient confidentiality. When the patient presents for surgery, they will be randomized to receive either preoperative pyridium or intraoperative fluorescein or no dye. Given the color differences between the dyes, blinding will not occur. The process for recruitment will be consistent and any deviations from the protocol will be reported to the Johns Hopkins Internal Review Board.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: