Uterine HemorrhageAQTH-EA-PIV-24NCT07877051
A Clinical Study of the Aqua Therapeutics Thermal Therapy Vapor Ablation System in Premenopausal Women With Abnormal Uterine Bleeding
A study testing Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) in people with Uterine Hemorrhage, run by Aqua Therapeutics, Inc. at 3 sites in Georgia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women only
- Conditions the study is for
- Uterine Hemorrhage
- What is being tested?
- Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 3 sitesGeorgia
- Study dates
- 8 Apr 2025to 31 Mar 2027
- Phase
- Interventional
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 30 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients will be eligible if, at screening (V-1), they will meet all of the following inclusion criteria except having a PBAC score ≥150 since this score can only be calculated at baseline visit (V0).
- 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.
Show all 9Show fewer
- Normal endometrial biopsy.
- Negative PAP test.
- Willingness to follow all study procedures, including attending all site visits, tests, and examinations. NOTE: diagnosis of AUB will include AUB history, current menstrual condition (collected at screening visit), physical examination (performed at screening and at baseline visit), blood test results (from blood samples collected at screening visit) and will be confirmed by a PBAC score ≥150 (at baseline visit).
Who cannot join
- BMI ≥40
- 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.
- Uterine cavity-length <4 cm or >6 cm (without cervix length).
- 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.
Show all 23Show fewer
- 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 malformation of the uterus, fibroid(s) distorting the uterine cavity, or large (> 1 cm) endometrial polyp(s).
- 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).
- Documented cervical dysplasia, complex or atypical endometrial hyperplasia, abdominal or pelvic cancer.
- 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, in the opinion of the Investigator may interfere with the participation to the study.
- 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).
- Participation in another investigational study within the previous 30 days.
- Recent history or suspicion of alcohol abuse or drug addiction.
- Inability to follow study procedures.
- History of allergic reactions to propofol and/or fentanyl.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Georgia3 sites, 3 recruiting
- Recruiting
LTD High Technology Hospital Medcenter
Batumi
Elene Kobiashvili, MD
- Recruiting
LTD Gagua Clinic
Tbilisi
Tinatin Gagua, MD
- Recruiting
LTD Todua Clinic
Tbilisi
Nino Chogovadze, MD
About this study
Official title: A Pre-Market, Pivotal, Interventional, Clinical Investigation to Evaluate the Performance and the Safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) in Premenopausal Women With Abnormal Uterine Bleeding (AUB)
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 A Pre-Market, Pivotal, Interventional, Clinical Investigation to Evaluate the Performance and the Safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) in premenopausal women with Abnormal Uterine Bleeding (AUB)
Read the detailed description
The Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) is a system designed to ablate uterine tissue by vapor thermal therapy technology. The ATTTVAS consists of a reusable Generator, a DISPOSABLE APPLICATOR, a DISPOSABLE CATHETER and a SYRINGE. The ATTTVAS is intended for outpatient use although it can easily be utilized in both a surgery centre and the operating room as well. This is a Pre-Market, Pivotal, Interventional, Clinical Investigation to Evaluate the Performance and the Safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) in premenopausal women with Abnormal Uterine Bleeding (AUB). For each patient, a total of 9 visits (8 on-site and 1 remote) will be planned according to the flowchart. Unscheduled visit(s) will be planned on-site according to Principal Investigator judgement. Additional visits should be performed before EOS visit; EOS visit should remain at 12 months ± 14 days. Each Subject, after signing the Informed Consent Form (ICF), will enter a screening phase (V-1) during which several assessments (e.g., demographics, medical history, current menstrual condition, blood analysis) will be conducted. At the screening visit, patients will receive a menstrual calendar and a PBAC to be completed. The PBAC score must be recorded as soon as available to confirm that the patient can be enrolled at baseline (PBAC must be ≥150). The PBAC score will also be recorded at each applicable visit. At baseline (V0) and at EOS, on site, patients will also complete the Menorrhagia Impact Questionnaire (MIQ). If the Investigator can complete all the assessments foreseen at baseline visit (V0) and V1-EA in one day, V0 and V1 may coincide. At V1, enrolled Subjects will undergo EA with the ATTTVAS. EA must be performed within 15-20 days from the beginning of the menstrual cycle. EA cannot be performed in the presence of heavy menstrual bleeding, but it can be performed in the presence of light bleeding/spotting. Sedation will be performed before the EA by intravenous administration of propofol and fentanyl. The duration (seconds) of the ablation cycle will be recorded on the CRF. After the procedure is completed, the PI will fill a questionnaire on procedural ease of use. Device deficiencies (if any) will be recorded. At discharge, after 24 hours (V2) and 1 week (V3) from discharge, patients will be asked to rate pain intensity on a Numeric Rating Scale (NRS). At discharge patients will receive a diary to record AEs and concomitant medications through the study period.
Follow-up on site visits will be performed after 1 week ± 2 days (V3), 12 weeks ± 14 days (V4), 24 weeks ± 14 days (V5), 36 weeks ± 14 days (V6) and 48 weeks ± 14 days from discharge (V7-EOS visit). Satisfaction with the procedure will be evaluated using a 5-Likert Scale (completed by patient and PI) at discharge and at EOS. Physical examination, monitoring of vital signs and AEs will be performed at each applicable visit. Current menstrual condition will be monitored during the entire study period. To evaluate the need for surgical or medical intervention to treat AUB after EA, any surgical or medical intervention required to treat AUB after EA will be recorded during the study. An Interim Analysis is planned when the clinical data collected from V-1 to V5 (included) for 50% of the patients will be available.
- Conditions
- Uterine Hemorrhage
- Being tested
- Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS)
- Medical subject headings
- Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the performance of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) by assessing the change in menstrual blood loss at End of Study (EOS) visit, as measured by the Pictorial Blood Loss Assessment Chart (PBAC) score.
PBAC is a visual tool used to estimate menstrual blood loss. The PBAC uses a set of pictures that represent different levels of blood flow during menstruation. Users compare their own blood flow to the pictures to estimate their menstrual blood loss. The patients should record the number of tampons and sanitary pads used each day during the bleeding episode by placing the number under the day and next to the box representing the amount of bleeding each time the patient change pad or tampon. The patients should Record clots by indicating whether they are the size of a coin in the small and large blood clot row under the appropriate day.
Measured: V0 (day 1 Baseline) and V7 (48 weeks after discharge)
Secondary outcomes (13)
To evaluate the performance of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) by assessing the change in menstrual blood loss during the study, as measured by the Pictorial Blood Loss Assessment Chart (PBAC) score.
PBAC is a visual tool used to estimate menstrual blood loss. The PBAC uses a set of pictures that represent different levels of blood flow during menstruation. Users compare their own blood flow to the pictures to estimate their menstrual blood loss. The patients should record the number of tampons and sanitary pads used each day during the bleeding episode by placing the number under the day and next to the box representing the amount of bleeding each time the patient change pad or tampon. The patients should Record clots by indicating whether they are the size of a coin in the small and large blood clot row under the appropriate day.
Measured: V0(day 1)V3(1 week after V1)V4(12 weeks afterV1)V5(24weeks after V1)V6 (36weeks after V1)V7 (48 weeks after V1)
To evaluate the effect of menstrual blood loss on the quality of life
To evaluate the effect of MBL on the quality of life (QoL), the Menorrhagia Impact Questionnaire (MIQ) will be completed by patients. MIQ is instrument for Bleeding-specific symptom and quality of life that measures impact of heavy menstrual bleeding with six items total on perceived amount of blood lost, impact on work, impact on physical activities, social activities, number of activities limited, and perceived impact of treatment on symptoms
Measured: V0(day 1) V7 (48 weeks after V1)
To evaluate pain intensity after treatment.
To evaluate pain intensity after treatment, a Numeric Rating Scale (NRS) - with number 0 representing no pain and number 10 representing unbearable pain will be used.
Measured: V1 (day 2, at discharge) V2 (phone call after 24hours after discharge); V3 (1 week after V1)
To evaluate procedure difficulty.
To evaluate the procedural ease of use, a questionnaire will be completed by the Investigator on the day of treatment. The PI will compile a multiple choice questionnaire and answer to some questions on procedural ease of use.
Measured: V1 (day 2 after Endometrial Ablation)
To evaluate menstrual changes (menstrual frequency, duration, regularity)
To monitor menstrual changes (menstrual frequency, duration, regularity), a menstrual calendar will be used by the patient.
Measured: V0(day 1) V5(24weeks after V1) V7 (48 weeks after V1)
To evaluate patient's satisfaction with the ATTTVAS.
To evaluate patient's satisfaction with the ATTTVAS, a 5-Likert Scale will be used. Here's a breakdown of a typical 5-point Likert scale: Strongly Disagree Disagree Neutral (or Neither Agree nor Disagree) Agree Strongly Agree This scale allows respondents to express the intensity of their feelings towards a given statement, making it easier to quantify subjective data. It's widely used because it's simple to understand and analyze.
Measured: V1 (day 2, at discharge) and V7 (48 weeks after V1)
To evaluate PI's satisfaction with the ATTTVAS.
- evaluate PI's satisfaction with the ATTTVAS, a 5-Likert Scale will be used. Here's a breakdown of a typical 5-point Likert scale: Strongly Disagree Disagree Neutral (or Neither Agree nor Disagree) Agree Strongly Agree This scale allows respondents to express the intensity of their feelings towards a given statement, making it easier to quantify subjective data. It's widely used because it's simple to understand and analyze.
Measured: V1 (day 2, at discharge) and V7 (48 weeks after V1)
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)
Measured: V1 (day 2, Endometrial ablation) V3(1 week after V1)V4(12 weeks afterV1)V5(24weeks after V1)V6 (36weeks after V1)V7 (48 weeks after V1) unscheduled visit (between V1 and V6)
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)
Measured: V1 (day 2, Endometrial ablation) V3(1 week after V1)V4(12 weeks afterV1)V5(24weeks after V1)V6 (36weeks after V1)V7 (48 weeks after V1) unscheduled visit (between V1 and V6)
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.
Measured: V1 (day 2, Endometrial ablation) V3(1 week after V1)V4(12 weeks afterV1)V5(24weeks after V1)V6 (36weeks after V1)V7 (48 weeks after V1) unscheduled visit (between V1 and V6)
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
Measured: V-1(40 days before baseline) and V7 (48 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)
Measured: V-1(40 days before baseline) and V7 (48 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.
Measured: V-1(40 days before baseline)V0(day 1)V1(day 2,EA and at discharge)V2(phone after 24h afterV1)V3(1 week after V1)V4(12 weeks afterV1)V5(24weeks after V1)V6 (36weeks after V1)V7 (48 weeks after V1) unscheduled visit (between V1 and V6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start8 Apr 2025
- Primary completion8 Apr 2026
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine HemorrhageStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Pre-Market, Pivotal, Interventional, Clinical Investigation to Evaluate the Performance and the Safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) in 43 premenopausal women with Abnormal Uterine Bleeding (AUB).
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aqua Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877051
- Sponsor's protocol ID
- AQTH-EA-PIV-24
- Acronym
- AQTH-EA-PIV-24
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No