Clinical Study on the Safety and the Performance of an Endometrial Ablation System in Women With Abnormal Uterine Bleeding (AUB) and Previous Cesarean Delivery.
NCT07925008, Not applicable, Recruiting, Aqua Therapeutics, Inc.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Clinical Study on the Safety and the Performance of an Endometrial Ablation System in Women With Abnormal Uterine Bleeding (AUB) and Previous Cesarean Delivery. | ClinicalTrials.gov |
| NCT number | NCT07925008 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 15 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Aqua Therapeutics, Inc. | ClinicalTrials.gov |
| Conditions | Menorrhagia | ClinicalTrials.gov |
| Interventions | Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Safety will be monitored through the reporting of the adverse events, serious adverse events and concomitant medications during the entire study duration. | 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) | 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. | ClinicalTrials.gov |
| Primary | To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through vital sign. | V1 (day 2, Endometrial ablation) and unscheduled visit that could be taken between phone call after 24hours after discharge and 12weeksAfterDischarge | Safety will be monitored through Blood pressure measurement. Blood pressure readings are typically expressed in millimeters of mercury (mmHg) | ClinicalTrials.gov |
| Primary | To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through vital signs. | V1 (day 2, Endometrial ablation) and unscheduled visit that could be taken between phone call after 24hours after discharge and 12weeksAfterDischarge | 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) | ClinicalTrials.gov |
| Primary | To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through vital signs. | V1 (day 2, Endometrial ablation) and unscheduled visit that could be taken between phone call after 24hours after discharge and 12weeksAfterDischarge | 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. | ClinicalTrials.gov |
| Primary | To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through laboratory data | V-1 (within 40 days before baseline); V5 (12 weeks after V1) | Blood analyses will include: Hemoglobin g/dL | ClinicalTrials.gov |
| Primary | To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through laboratory data | V-1 (within 40 days before baseline); V5 (12 weeks after V1) | Blood analyses will include: \- Hematology: complete blood count (including red blood cell count, white blood cell count, platelet count) | ClinicalTrials.gov |
| Secondary | 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. | V0 (baseline); V5(12 weeksAfterDischarge) | 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 | ClinicalTrials.gov |
| Secondary | To evaluate the effect of menstrual blood loss on the quality of life | V0 (baseline); V5(12 weeksAfterDischarge) | 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. | ClinicalTrials.gov |
| Secondary | To evaluate pain intensity after treatment | V1 (day 2, at discharge); V2(phone call after 24hours after discharge);V3(1week after V1) | To evaluate pain intensity after treatment, a Numeric Rating Scale (NRS) - with 0 representing no pain and 10 representing unbearable pain will be used. | ClinicalTrials.gov |
| Secondary | To evaluate procedure difficulty | V1 (day 2, at Endometrial Ablation) | 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. | ClinicalTrials.gov |
| Secondary | To evaluate menstrual changes (menstrual frequency). | V0 (baseline); V5(12 weeksAfterDischarge) | 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. | ClinicalTrials.gov |
| Secondary | To evaluate menstrual changes (menstrual duration). | V0 (baseline); V5(12 weeksAfterDischarge) | 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. | ClinicalTrials.gov |
| Secondary | To evaluate menstrual changes (menstrual regularity). | V0 (baseline); V5(12 weeksAfterDischarge) | 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). | ClinicalTrials.gov |
| Secondary | To evaluate patient's satisfaction with the ATTTVAS. | V1 (day 2, at discharge) V5(12 weeksAfterDischarge) | 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. | ClinicalTrials.gov |
| Secondary | To evaluate PI's satisfaction with the ATTTVAS. | V1 (day 2, at Endometrial Ablation) | 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. | ClinicalTrials.gov |
| Other | Assessment of Device Deficiency/Incidents. | V1 (day 2, at Endometrial Ablation) | Device deficiency/incident information will be collected by the investigator or its delegates on the CRF's. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)