Trial · NCT07877051
A Clinical Study of the Aqua Therapeutics Thermal Therapy Vapor Ablation System in Premenopausal Women With Abnormal Uterine Bleeding
NCT07877051, Not applicable, Recruiting, Aqua Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Study of the Aqua Therapeutics Thermal Therapy Vapor Ablation System in Premenopausal Women With Abnormal Uterine Bleeding. Trials, record NCT07877051. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07877051
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study of the Aqua Therapeutics Thermal Therapy Vapor Ablation System in Premenopausal Women With Abnormal Uterine Bleeding
- NCT number
- NCT07877051
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 43 participants, estimated
- Lead sponsor
- Aqua Therapeutics, Inc.
- Conditions
- Menorrhagia
- Interventions
- Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS)
- First posted
- 2026-10-16
- Last updated
- 2026-10-30
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | V0 (day 1 Baseline) and V7 (48 weeks after discharge) | 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. |
| 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(day 1)V3(1 week after V1)V4(12 weeks afterV1)V5(24weeks after V1)V6 (36weeks after V1)V7 (48 weeks after V1) | 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. |
| Secondary | To evaluate the effect of menstrual blood loss on the quality of life | V0(day 1) V7 (48 weeks after V1) | 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 |
| Secondary | To evaluate pain intensity after treatment. | V1 (day 2, at discharge) V2 (phone call after 24hours after discharge); V3 (1 week after V1) | 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. |
| Secondary | To evaluate procedure difficulty. | V1 (day 2 after 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. |
| Secondary | To evaluate menstrual changes (menstrual frequency, duration, regularity) | V0(day 1) V5(24weeks after V1) V7 (48 weeks after V1) | To monitor menstrual changes (menstrual frequency, duration, regularity), a menstrual calendar will be used by the patient. |
| Secondary | To evaluate patient's satisfaction with the ATTTVAS. | V1 (day 2, at discharge) and V7 (48 weeks after V1) | 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. |
| Secondary | To evaluate PI's satisfaction with the ATTTVAS. | V1 (day 2, at discharge) and V7 (48 weeks after V1) | o 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. |
| Secondary | 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) 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) | Safety will be monitored through Blood pressure measurement. Blood pressure (both pressures) readings are typically expressed in millimeters of mercury (mmHg) |
| Secondary | 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) 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) | 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) |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07877051
GET https://conductscience.org/api/trials/v1/NCT07877051/registered