Trial reportInternational journal of women's health2021
Water Vapor Endometrial Ablation for Heavy Menstrual Bleeding: 36-Month Follow-Up of a Prospective, Multicenter Pivotal Clinical Trial.
Trial report in International journal of women's health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01979861 (A Prospective, Multicenter, Clinical Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor System for the Treatment of Excessive Uterine Bleeding), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective, Multicenter, Clinical Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor System for the Treatment of Excessive Uterine Bleeding
Who cites it
1 citing paper in PubMed, 3 citations in OpenAlex.
- Endometrial Cryoablation for the Treatment of Heavy Menstrual Bleeding: 36-Month Outcomes from the CLARITY Study.International journal of women's health · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
objectiveTo report 36-month follow-up of a pivotal trial that evaluated the safety and effectiveness of the AEGEA Water Vapor System for the treatment of heavy menstrual bleeding (HMB) secondary to Abnormal Uterine Bleeding due to Endometrial disorders or Leiomyomata (AUB-E and AUB-L).
methodsA prospective, multicenter, single-arm clinical trial at 14 sites in the US, Canada, Mexico, and the Netherlands. Inclusion criteria included a Pictorial Blood Loss Assessment (PBLAC, Higham) score ≥150 and allowed treatment of subjects with leiomyomata classified by the International Federation of Gynecology and Obstetrics (FIGO) Types 2-6 up to 4 cm in diameter, a uterine cavity up to 12 cm in length (uterine sound), Essure
resultsOne hundred and fifty-five premenopausal women aged 30 to 50 years were enrolled from September 2014 through May 2015. Water vapor endometrial ablation was performed under varying anesthesia/sedation regimens in offices, surgical centers and operating rooms. There were 6 procedure-related adverse events that occurred between 12- and 36-month follow-up, 1 of which was deemed serious (hematometra managed successfully hysteroscopically). Seventy-two percent reported amenorrhea or light menstrual flow. The mean quality of life (MIQ) score improved from 14.7 at baseline to 6.4. Ninety-three percent reported "Satisfied" or "Very Satisfied." Post-ablation hysterectomy for any indication was performed in 6.5% of patients, and the total rate of re-intervention for bleeding was 7.1%.
conclusionOutcomes 36-months after water vapor endometrial ablation for HMB are consistent with 12- and 24-month follow-up results in all subgroups evaluated. The AEGEA Water Vapor System increases the population of patients amenable to efficacious and acceptable treatment of Heavy Menstrual Bleeding (HMB) due to Abnormal Uterine Bleeding (AUB-E,-L). CinicalTrials.gov NCT01979861 registered November 8, 2013.
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