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NCT06430320 · ClinicalTrials.gov registry record
Ascertaining Longterm Outcomes of Fibroid Treatments
A clinical trial, sponsored by Henry Ford Health System.
- Active
- Registry status
- 700
- Enrollment target
NCT06430320: Active study, sponsored by Henry Ford Health System.
NCT06430320 is a clinical trial that is active but no longer recruiting, run by Henry Ford Health System. The registered enrollment target is 700 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06430320 is active but no longer recruiting, sponsored by Henry Ford Health System.
- ACTIVE NOT RECRUITING
- Registry status
- 700 participants
- Enrollment target
Study 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 study's analyses will focus on comparisons of primary and secondary outcomes among women.
Primary Outcome
The need for another uterine fibroid treatment procedure
Interventions
- OTHER NA- no intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2024-05-20 |
| Est. Completion | 2027-08 |
What the registry record for NCT06430320 still lists
NCT06430320 is an observational study that tracks outcomes without assigning an intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which NA- no intervention is the first listed.
NCT06430320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06430320 about?
NCT06430320 is a clinical study titled "Ascertaining Longterm Outcomes of Fibroid Treatments". 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 parti...
What is the current status of trial NCT06430320?
This trial is currently active not recruiting. The enrollment target is 700 participants. The study started on 2024-05-20. Estimated completion is 2027-08.
What interventions are being tested in trial NCT06430320?
The interventions under investigation include: NA- no intervention (OTHER).
Who is sponsoring clinical trial NCT06430320?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
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