Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430320
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-31
First Post:
2024-05-21
Brief Title:
Ascertaining Longterm Outcomes of Fibroid Treatments
Sponsor:
Henry Ford Health System
Organization:
Henry Ford Health System
Study Overview
Official Title:
Long Term Effectiveness of Uterine Sparing Fibroid Treatments
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
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:
ALOFT
Brief Summary:
The goal of the ALOFT study is to understand the health of women in the 12 years following a uterine fibroid UF treatment ALOFT is a multi-center prospective observational cohort study of approximately 700 women who have undergone uterine-sparing treatment procedures for UF and previously participated in the longitudinal studies COMPARE-UF NCT02260752 or ULTRA NCT02100904
The primary uterine sparing treatment procedures undergone by study participants are myomectomy endometrial ablation EA uterine artery embolization UAE and laparoscopic radiofrequency ablation RFA A smaller number of women may be studied who underwent focused ultrasound intrauterine device IUD and medical management
Two follow-up study contacts with COMPARE-UF and ULTRA participants will occur to assess changes in UF symptoms and treatment failure which is defined as the need for another UF treatment procedure Questionnaires will be used to collect data on patient-reported characteristics and outcomes and quality of life
The studys analyses will focus on comparisons of primary and secondary outcomes among women
The primary uterine sparing treatment procedures undergone by study participants are myomectomy endometrial ablation EA uterine artery embolization UAE and laparoscopic radiofrequency ablation RFA A smaller number of women may be studied who underwent focused ultrasound intrauterine device IUD and medical management
Two follow-up study contacts with COMPARE-UF and ULTRA participants will occur to assess changes in UF symptoms and treatment failure which is defined as the need for another UF treatment procedure Questionnaires will be used to collect data on patient-reported characteristics and outcomes and quality of life
The studys analyses will focus on comparisons of primary and secondary outcomes among women
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