Trial · NCT07877051
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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) |
| 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 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. |
| Secondary | To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through laboratory data | V-1(40 days before baseline) and V7 (48 weeks after V1) | Blood analyses will include: \- Hemoglobin g/dL |
| Secondary | To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through laboratory data | V-1(40 days before baseline) and V7 (48 weeks after V1) | Blood analyses will include: \- Hematology: complete blood count (including red blood cell count, white blood cell count, platelet count) |
| Secondary | Safety will be monitored through the reporting of the adverse events, serious adverse events and concomitant medications during the entire study duration. | 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) | 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. |
| Other | Assessment of Device Deficiency/Incidents | V1 (day 2 Endometrial Ablation) | Device deficiency/incident information will be collected by the investigator or its delegates on the CRF's. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07877051/registered