Steam power: could vapor ablation offer a new way to stop heavy periods?

NCT ID NCT07580560

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tested a new device that uses vapor (steam) to destroy the lining of the uterus in 10 premenopausal women with heavy menstrual bleeding who no longer want children. The goal was to see if the procedure is safe. If successful, it could provide a less invasive alternative to hysterectomy for controlling abnormal uterine bleeding.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) – a device that uses vapor to destroy the uterine lining
What this could lead to
If it works, this could offer a less invasive, outpatient option for women with heavy bleeding who are done having children, potentially avoiding more major surgery.
What could go wrong
This is a very early, first-in-human pilot study with only 10 participants. The device may not be safe or effective in larger groups, and vapor ablation is a new technique with unknown long-term outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

10 people

The number who actually took part.

Started

Nov 2024

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 55 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed patient informed consent form (ICF). 2. Females aged ≥ 30 years and ≤ 55 years at baseline with no desire to conceive, with or without simple endometrial hyperplasia (without atypia). 3. Diagnosis of AUB. 4. Premenopausal (follicle-stimulating hormone level ≤ 40 mIU/mL), women who don't want to receive hormonal treatment or who have failed to respond to hormonal treatment. 5. Pictorial Blood Loss Assessment Chart (PBAC) score ≥150 at baseline. 6. Normal endometrial biopsy. 7. Negative PAP test. 8. Willingness to follow all study procedures, including attending all site visits, tests, and examinations. Exclusion Criteria: 1. BMI ≥35 2. Postmenopausal status. 3. Undiagnosed vaginal bleeding. 4. A patient with a history of a prior completed endometrial ablation procedure and/or endometrial resection (including endometrial ablation/resection performed immediately prior to the ATTTVAS Ablation Treatment) regardless of the modality by which it was performed. 5. Previous uterine surgery. 6. Not willing to avoid the use of vaginal ring, hormonal intrauterine device (concomitant IUD such as Essure is not allowed prior to the ATTTVAS Ablation Treatment), oral contraceptives during the study period. 7. Pregnant or breastfeeding. 8. Less than 1-year post-partum. 9. Any contraindication to endometrial ablation. 10. History of previous classical cesarean section or transmural myomectomy, including hysteroscopic and/or laparoscopic myomectomy performed immediately prior to the ATTTVAS Ablation Treatment. 11. Confirmed pelvic inflammatory disease, active/acute endometritis, sexually transmitted disease, bacteremia, sepsis, other active local and/or systemic infection. 12. Active genital or urinary tract infection (e.g., cervicitis, vaginitis, endometritis, salpingitis or cystitis) at the time of treatment. 13. Congenital malformations of the female genital tract. 14. Subjects with suspected or known coagulopathies or receiving anticoagulation therapy. 15. A patient currently on medications that could thin the myometrial muscle, such as long-term steroid use (except for inhaler or nasal therapy for asthma). 16. Documented cervical dysplasia, complex or atypical endometrial hyperplasia, abdominal or pelvic cancer. 17. Presence of any relevant severe condition or clinically relevant abnormal laboratory parameters that in the opinion of the Investigator may interfere with the participation to the study. 18. Presence of any relevant severe organic, systemic, or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant in Investigator's opinion. 19. Active malignant neoplasm of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are also acceptable). 20. Participation in another investigational study within the previous 30 days. 21. Recent history or suspicion of alcohol abuse or drug addiction. 22. Inability to follow study procedures. 23. History of allergic reactions to propofol and/or fentanyl.

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Conditions

The condition(s) this trial relates to.

Uterine Hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Milano

    Milan, Italy

  • Roma

    Roma, Italy

  • Veldhoven

    Veldhoven, Netherlands

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