Uterine FibroidALOFTNCT06430320
Ascertaining Longterm Outcomes of Fibroid Treatments
An observational study of Uterine Fibroid, run by Henry Ford Health System at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Fibroid
- How many people
- 700 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 May 2024to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Participants who were previously enrolled in either the COMPARE-UF or ULTRA study
Who may be able to join
- Participant has to have been enrolled in either the COMPARE-UF or ULTRA study
- Participant had a uterine-sparing fibroid treatment at enrollment in COMPARE-UF or ULTRA study
Who cannot join
- Individuals who were not consented into the original COMPARE-UF or ULTRA study
- Individuals who did not have a uterine-sparing fibroid treatment at enrollment in COMPARE-UF or ULTRA study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Henry Ford Health
Detroit, Michigan, 48202
Mayo Clinic
Rochester, Minnesota, 55905
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Long Term Effectiveness of Uterine Sparing 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 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.
Read more
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.
- Conditions
- Uterine Fibroid
- Being tested
- NA- no intervention
- Keywords
- Uterine fibroid treatment, Multi-center, prospective, observational cohort study, Uterine-sparing treatment procedures, Patient-reported outcomes, Quality of life
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NA- no interventionOther
NA- no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure
The need for another uterine fibroid treatment procedure
Measured: Up to 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start20 May 2024
- Primary completion31 Mar 2025
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, University of California, San Francisco, University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Ganesa Wegienka, Henry Ford Health System
- Investigators
- Ganesa Wegienka, PhD, Principal investigator, Henry Ford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430320
- Sponsor's protocol ID
- R9NXPE2GTCN9
- Acronym
- ALOFT
- Status last verified
- May 2026
- First submitted
- 21 May 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Effectiveness of Uterine Sparing Fibroid Treatments
- ClinicalTrials.gov ID
- NCT06430320
- Acronym / sponsor ID
- ALOFT / R9NXPE2GTCN9
- Conditions
- Uterine Fibroid
- Keywords
- Uterine fibroid treatment, Multi-center, prospective, observational cohort study, Uterine-sparing treatment procedures, Patient-reported outcomes, Quality of life
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Mayo Clinic, University of California, San Francisco, University of North Carolina, Chapel Hill
- Study start
- 20 May 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who were previously enrolled in either the COMPARE-UF or ULTRA study
Key inclusion criteria (2 listed)
- Participant has to have been enrolled in either the COMPARE-UF or ULTRA study
- Participant had a uterine-sparing fibroid treatment at enrollment in COMPARE-UF or ULTRA study
Key exclusion criteria (2 listed)
- Individuals who were not consented into the original COMPARE-UF or ULTRA study
- Individuals who did not have a uterine-sparing fibroid treatment at enrollment in COMPARE-UF or ULTRA study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NA- no interventionNA- no intervention | Other | – |
Primary outcome
Time to treatment failure
Time frame: Up to 12 years
The need for another uterine fibroid treatment procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- ALOFT study landing pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Life Study: Lifestyle Intervention in Fibroid Elimination
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Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ganesa Wegienka, PhD principal investigator
Henry Ford Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Fibroid, run by Henry Ford Health System at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to treatment failure (time frame: Up to 12 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.