Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study

NCT07580560 | Completed DMC

• 1 other identifier: AQTH-EA-22
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 3

Brief Summary

Abnormal uterine bleeding (AUB) is defined as "flow outside of normal volume, duration, regularity, or frequency". Acute AUB is excessive bleeding that requires immediate intervention to prevent further blood loss. Chronic AUB refers to irregularities in menstrual bleeding for most of the previous 6 months. AUB can be frequent or infrequent, prolonged, irregular, or heavy. Heavy menstrual bleeding (HMB) is defined as "excessive menstrual blood loss which interferes with a woman's physical, social, emotional and/or material quality of life". Causes of AUB are classified as polyps, adenomyosis, leiomyomas (AUB-L), malignancy and premalignant conditions, coagulopathy, ovulatory disorders (AUB-O), endometrial disorders (AUB-E), iatrogenic, and ''not classified'' . AUB affects approximately one in four women between 30 and 50 years of age, with serious implications on woman's quality of life (QoL). Endometrial ablation (EA) is a uterus-preserving procedure that aims to destroy or remove the endometrial tissue in selected women who have no desire for future fertility. EA has become an alternative to hysterectomy in the treatment of AUB because it is less invasive and has a shorter recovery period. At present, many different techniques are available to remove the endometrial tissue. Resectoscopic endometrial ablation (REA) consists of targeted endometrial destruction under direct hysteroscopic visualization. REA techniques include endometrial laser ablation, transcervical resection of the endometrium, and rollerball endometrial ablation. Non-resectoscopic endometrial ablation (NREA) uses a variety of energy sources to non-selectively destroy the endometrial lining and include thermal balloon endometrial ablation, microwave endometrial ablation, hydrothermal ablation, bipolar radiofrequency endometrial ablation, endometrial cryotherapy, and more recently vapor endometrial ablation. NREA technologies require short surgical time and can also be performed in the outpatient setting. Vapor EA is one of the newest approaches in the field. In this context, the Aqua Therapeutics Thermal Therapy Vapor Ablation system (ATTTVAS; AQUA Therapeutics Inc.) is a novel system designed to ablate uterine tissue using vapor thermal therapy technology. The ATTTVAS is indicated to ablate the endometrial lining of the uterus in premenopausal women with abnormal uterine bleeding (AUB) due to benign causes for whom childbearing is complete. In this Pre-Market, First-In-Human, Pilot, Interventional, Clinical Investigation we aim to evaluate the Safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) in premenopausal women with AUB.

Conditions

Uterine Hemorrhage

Outcome Measures

Primary Outcomes (6)

• To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through vital sign.

  Safety will be monitored through Blood pressure measurement. Blood pressure (both pressures) readings are typically expressed in millimeters of mercury (mmHg)

  V1 (day 2, Endometrial ablation) V3 (1 week after V1) and V4 (6 weeks after V1) and unscheduled visit (between V1 and V4)

• To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through vital signs.

  Safety will be monitored through Heart Rate measurement. Heart rate is the frequency of the heartbeat measured by the number of contractions of the heart per minute (beats per minute, or bpm)

  V1 (day 2, Endometrial ablation) V3 (1 week after V1 ) and V4 (6 weeks after V1)and unscheduled visit (between V1 and V4)

• To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through vital signs.

  Safety will be monitored through measurement of the oxygen levels. 2 refers to the percentage of oxygen-saturated hemoglobin relative to total hemoglobin in the blood. The measurement of O2 is performed using a non-invasive device known as a pulse oximeter.

  V1 (day 2, Endometrial ablation) V3 (1 week after V1 ) and V4 (6 weeks after V1) and unscheduled visit (between V1 and V4)

• To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through laboratory data

  Blood analyses will include: \- Hemoglobin g/dL

  V-1 (within 40 days before baseline); V4 (6 weeks after V1)

• To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through laboratory data

  Blood analyses will include: \- Hematology: complete blood count (including red blood cell count, white blood cell count, platelet count)

  V-1 (within 40 days before baseline); V4 (6 weeks after V1)

• Safety will be monitored through the reporting of the adverse events, serious adverse events and concomitant medications during the entire study duration.

  The event, date of onset, severity, duration, and relationship to the device will be recorded. Subjects will receive a diary to record any deviation from the normal health status as well as any concomitant medication taken.

  V-1 (within 40 days before baseline); V0 (day 1 Baseline) V1 (day 2, Endometrial ablation and at discharge) V2 (phone call after 24h after discharge); V3 (1 week after V1 ) and V4 (6 weeks after V1) and and unscheduled visit (between V1 and V4)

Secondary Outcomes (7)

• To evaluate the change of menstrual blood loss, the pictorial blood loss assessment chart (PBAC) score will be assessed

  V0 (day 1 Baseline) and V4 (6 weeks after V1)

• To evaluate the effect of menstrual blood loss on the quality of life

  V0 (day 1 Baseline) and V4 (6 weeks after V1)

• To evaluate pain intensity after treatment.

  V1 (day 2, at discharge) V2 (phone call after 24h after V1); V3 (1 week after V1)

• To evaluate procedure difficulty.

  V1 (day 2 after Endometrial Ablation)

• To evaluate menstrual changes (menstrual frequency, duration, regularity).

  V-1 (within 40 days before baseline); V0 (day 1 Baseline) V2 (phone call after 24h after V1); V3 (1 week after V1) and V4 (6 weeks after V1)

Other Outcomes (1)

• Assessment of Device Deficiency/Incidents.

  V1 (day 2 Endometrial Ablation)

Study Arms (1)

Treatment with Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) medical device

EXPERIMENTAL

All Patients shall be screened for initial study eligibility by the Principal Investigator at the investigational site. Potential candidates, that according to the investigator judgment should be treated with IP, will be identified, with the assessment of their eligibility criteria, by the study site Principal Investigator and research staff. Patients will be considered to be enrolled in the study once they have met all of the inclusion and none of the exclusion criteria. Patients who do not meet the criteria will not be enrolled in the study. The patient involvement in the study will last until the EOS visit.

Device: Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS)

Interventions

Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) DEVICE

The Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) is indicated to ablate the endometrial lining of the uterus in premenopausal women with abnormal uterine bleeding (AUB) due to benign causes for whom childbearing is complete. The ATTTVAS is intended to be used by qualified healthcare professionals specifically trained in the field of endometrial ablation. The ATTTVAS is intended for outpatient use although it can easily be utilized in both a surgery centre and the operating room as well.

Treatment with Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) medical device

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signed patient informed consent form (ICF).
• Females aged ≥ 30 years and ≤ 55 years at baseline with no desire to conceive, with or without simple endometrial hyperplasia (without atypia).
• Diagnosis of AUB.
• 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.
• Pictorial Blood Loss Assessment Chart (PBAC) score ≥150 at baseline.
• Normal endometrial biopsy.
• Negative PAP test.
• Willingness to follow all study procedures, including attending all site visits, tests, and examinations.

You may not qualify if:

• BMI ≥35
• Postmenopausal status.
• Undiagnosed vaginal bleeding.
• 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.
• Previous uterine surgery.
• 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.
• Pregnant or breastfeeding.
• Less than 1-year post-partum.
• Any contraindication to endometrial ablation.
• History of previous classical cesarean section or transmural myomectomy, including hysteroscopic and/or laparoscopic myomectomy performed immediately prior to the ATTTVAS Ablation Treatment.
• Confirmed pelvic inflammatory disease, active/acute endometritis, sexually transmitted disease, bacteremia, sepsis, other active local and/or systemic infection.
• Active genital or urinary tract infection (e.g., cervicitis, vaginitis, endometritis, salpingitis or cystitis) at the time of treatment.
• Congenital malformations of the female genital tract.
• Subjects with suspected or known coagulopathies or receiving anticoagulation therapy.
• 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).

Sponsors & Collaborators

• Aqua Therapeutics, Inc.: lead

Study Sites (3)

Milano

Milan, Italy

Location

Roma

Roma, Italy

Location

Veldhoven

Veldhoven, Netherlands

Location

MeSH Terms

Conditions

Uterine Hemorrhage

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In this Pre-Market, First-In-Human, Pilot, Interventional, Clinical Investigation we aim to evaluate the Safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) in 10 premenopausal women with AUB.

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 12, 2026
• Study Start: November 28, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); IT (2)