An interventional study of Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) in Menorrhagia, sponsored by Aqua Therapeutics, Inc.. Recruiting at 2 sites in 2 countries. Open to female participants aged 30 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Aqua Therapeutics, Inc. · Not applicable, Interventional, and Treatment
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, Traditional Feasibility, Pilot, Interventional, Clinical Investigation we aim to evaluate the Safety and the Performance of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) In Premenopausal Women with Abnormal Uterine Bleeding (AUB) and a History of Cesarean Section.
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. For each participant enrolled, a total of 7 visits (5 on-site and 2 remote) will be planned according to the flowchart. One unscheduled visit can be planned on-site according to Principal Investigator's judgement between V2 and V5/EOS visits. If the Investigator can complete all the assessments foreseen at baseline visit (V0) and V1-EA in one day, V0 and V1 may coincide.
Each participant, 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, the participants 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 subject can be enrolled at baseline (PBAC must be ≥150). The PBAC score will also be recorded at the EOS visit. At baseline (V0) and at EOS, on site, the participants will also complete the Menorrhagia Impact Questionnaire (MIQ). At V1, the enrolled participants 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 EA as per clinical practice. The duration (seconds) of the ablation cycle (the treatment typically runs for 90 seconds) will be recorded on the CRF. After the procedure is completed, the PI will fill in a questionnaire on procedural ease of use. Device deficiencies (if any) will be recorded. At discharge, after 24 hours and 1 week from discharge, the participants will be asked to rate pain intensity on a Numeric Rating Scale (NRS). At discharge, the participants will receive a diary, to record AEs and concomitant medications, a PBAC and a menstrual calendar to be completed during the study period. Satisfaction with the procedure will be evaluated using a 5-Likert Scale (completed by the PI and the participants) at discharge and EOS visits. Gynecological examination and vital signs monitoring will be performed at applicable visits (see flowchart). AEs, concomitant medications and 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.
A Data and Safety Monitoring Board (DSMB), appointed by the Sponsor, will review the adverse events reported in the study and make recommendations to the Sponsor regarding any actions (continue, suspend, modify, or stop the clinical investigation) to be taken. For safety reasons, the first DSMB meeting will be triggered after the occurrence of 5 SADEs related to the ATTTVAS (if any).
206 studies on the registry are indexed under Menorrhagia; 35 are open to participants now.
This study's planned enrollment of 15 is below the median of 95 across 149 interventional studies indexed under Menorrhagia.
Browse Menorrhagia studies →Aqua Therapeutics, Inc. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
History of allergic reactions to any components used in the sedation protocol at the site.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
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.
Time frame: V-1(within40 days before baseline);V0 (baseline); V1 (day 2, EndoAblation_discharge)V2(phone call after 24hours after discharge);V3(1week after V1)V4(6 weeks afterV1);unscheduled visit (betweenV2 andV5);V5(12weeksAfterDischarge)
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 readings are typically expressed in millimeters of mercury (mmHg)
Time frame: V1 (day 2, Endometrial ablation) and unscheduled visit that could be taken between phone call after 24hours after discharge and 12weeksAfterDischarge
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)
Time frame: V1 (day 2, Endometrial ablation) and unscheduled visit that could be taken between phone call after 24hours after discharge and 12weeksAfterDischarge
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.
Time frame: V1 (day 2, Endometrial ablation) and unscheduled visit that could be taken between phone call after 24hours after discharge and 12weeksAfterDischarge
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
Time frame: V-1 (within 40 days before baseline); V5 (12 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)
Time frame: V-1 (within 40 days before baseline); V5 (12 weeks after V1)
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
Time frame: V0 (baseline); V5(12 weeksAfterDischarge)
To evaluate the effect of menstrual blood loss on the quality of life
To evaluate the effect of menstrual blood loss on the quality of life, 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. Total MIQ score range: 4 to 21. Higher scores indicate a worse menorrhagia-related quality of life, meaning greater perceived menstrual blood loss and greater interference with daily, social, physical, and work activities.
Time frame: V0 (baseline); V5(12 weeksAfterDischarge)
To evaluate pain intensity after treatment
To evaluate pain intensity after treatment, a Numeric Rating Scale (NRS) - with 0 representing no pain and 10 representing unbearable pain will be used.
Time frame: V1 (day 2, at discharge); V2(phone call after 24hours after discharge);V3(1week 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.
Time frame: V1 (day 2, at Endometrial Ablation)
To evaluate menstrual changes (menstrual frequency).
To monitor menstrual changes (menstrual frequency), a menstrual calendar will be used by the patient. Menstrual frequency is the length of the menstrual cycle, measured as the number of days between the first day of one menstrual period and the first day of the subsequent menstrual period.
Time frame: V0 (baseline); V5(12 weeksAfterDischarge)
To evaluate menstrual changes (menstrual duration).
To monitor menstrual changes (menstrual duration), a menstrual calendar will be used by the patient. Menstrual duration is the number of days of menstrual bleeding during a menstrual cycle, measured from the first day of menstrual bleeding to the last day of bleeding of the same menstrual period.
Time frame: V0 (baseline); V5(12 weeksAfterDischarge)
To evaluate menstrual changes (menstrual regularity).
To monitor menstrual changes (menstrual regularity), a menstrual calendar will be used by the patient. Menstrual regularity is defined as the consistency with which menstrual cycles occur at predictable intervals over time. It is assessed based on the variability in cycle length between consecutive menstrual cycles. The unit of measure is categorical (Regular/Irregular).
Time frame: V0 (baseline); V5(12 weeksAfterDischarge)
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.
Time frame: V1 (day 2, at discharge) V5(12 weeksAfterDischarge)
To evaluate PI's satisfaction with the ATTTVAS.
To 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.
Time frame: V1 (day 2, at Endometrial Ablation)
Assessment of Device Deficiency/Incidents.
Device deficiency/incident information will be collected by the investigator or its delegates on the CRF's.
Time frame: V1 (day 2, at Endometrial Ablation)
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Aqua Therapeutics, Inc.