AEGEA Vapor-Based Endometrial Ablation: Perihysterectomy Proof of Concept

Garza-Leal, J.; Hernandez, I.; Castillo, L.; Coad, James E.

doi:10.1016/j.jmig.2009.08.244

“…With condensation from gas to liquid, energy is released, which in turn produces the desired tissue effect [2]. Post-treatment histologic studies of the endometrium and myometrium in subjects who had undergone water vapor ablation revealed no carbonization or heat fixation of tissue [3,4]. Furthermore, the conforming nature of water vapor allowed the inclusion of this technique in the pivotal clinical trial of subjects with uterine cavity lengths of up to 12 cm and nonobstructing International Federation of Gynecologic and Obstetrics (FIGO) type II to VI leiomyomata ≤4 cm [2].…”

mentioning

confidence: 99%

Post-Ablation Cavity Evaluation: A Prospective Multicenter Observational Clinical Study to Evaluate Hysteroscopic Access to the Uterine Cavity 4 Years after Water Vapor Endometrial Ablation for the Treatment of Heavy Menstrual Bleeding

Johns

¹

,

Garza-Leal

²

,

Diamond

³

et al. 2020

Journal of Minimally Invasive Gynecology

3

1

0

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Patients who have undergone endometrial ablation may present a diagnostic challenge when they subsequently develop vaginal bleeding, pelvic pain, or postmenopausal bleeding. Extensive scarring of the uterine cavity often precludes evaluation and/or conservative treatment. For further research on this topic, we performed hysteroscopic examination in study subjects a mean duration of 4 years after they had undergone water vapor endometrial ablation. Design: Prospective, multicenter, observational clinical study. Setting: Eight private practice or outpatient sites in the United States and Mexico. Patients: Seventy subjects who had completed their 36-month follow-up in the AEGEA Pivotal Trial. Interventions: Diagnostic hysteroscopy. Measurements and Main Results: The subjects were screened for general health and infection and underwent diagnostic hysteroscopy. Menstrual bleeding status was recorded. The video of the hysteroscopic examination was analyzed by an independent reviewer, who assessed uterine cavity access and visualization of the cornua and tubal ostia as well as characterized adhesions on the basis of the criteria by March et al. An independent reviewer also subjectively assessed whether Pipelle endometrial biopsy or intrauterine device placement would be feasible. Uterine cavity access was achieved in 90% (63/70) of subjects. Among subjects with cavity access, the cornua and ostia were visualized in 79% (50/63) and adhesions were absent in 75% (47/63), with only 2 women having severe adhesions (3%, 2/63). Biopsy was projected to be feasible in 86% (62/70) and intrauterine device placement in 60% (42/70) of all subjects. The subjects' bleeding statuses were not correlated with uterine cavity access. The results were consistent for subjects with large uterine cavities and International Federation of Gynecologic and Obstetrics type II to VI myomas ≤4 cm. Conclusion: Water vapor endometrial ablation preserved an accessible uterine cavity and visualization of the ostia in most subjects, with minimal incidence of severe adhesions, a mean of 4 years after the ablation procedure.

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“…[12][13][14] Several published studies have demonstrated that NovaSure can safely treat AUB with excellent outcomes in women without cirrhosis. 8,12,13,[15][16][17] However, data on NovaSure treatment of AUB in cirrhotic women are lacking, and the efficacy and safety of NovaSure treatment in this population have not been well established. Thus, we performed a single-center, prospective, observational study to investigate the efficacy and safety of NovaSure treatment in cirrhotic women with AUB compared to those in non-cirrhotic women with AUB.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of endometrial ablation for treating abnormal uterine bleeding in pre‐ and postmenopausal women with liver cirrhosis

Liu

¹

,

Li

²

,

Liu

³

et al. 2016

J of Obstet and Gynaecol

3

0

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show abstract

“…With condensation from gas to liquid, energy is released, which in turn produces the desired tissue effect [2]. Post-treatment histologic studies of the endometrium and myometrium in subjects who had undergone water vapor ablation revealed no carbonization or heat fixation of tissue [3,4]. Furthermore, the conforming nature of water vapor allowed the inclusion of this technique in the pivotal clinical trial of subjects with uterine cavity lengths of up to 12 cm and nonobstructing International Federation of Gynecologic and Obstetrics (FIGO) type II to VI leiomyomata ≤4 cm [2].…”

mentioning

confidence: 99%

Post-Ablation Cavity Evaluation: A Prospective Multicenter Observational Clinical Study to Evaluate Hysteroscopic Access to the Uterine Cavity 4 Years After Water Vapor Endometrial Ablation for the Treatment of Heavy Menstrual Bleeding

Johns

¹

,

Garza-Leal

²

,

Diamond³

et al. 2021

Obstetrical &Amp; Gynecological Survey

View full text Add to dashboard Cite

Patients who have undergone endometrial ablation may present a diagnostic challenge when they subsequently develop vaginal bleeding, pelvic pain, or postmenopausal bleeding. Extensive scarring of the uterine cavity often precludes evaluation and/or conservative treatment. For further research on this topic, we performed hysteroscopic examination in study subjects a mean duration of 4 years after they had undergone water vapor endometrial ablation. Design: Prospective, multicenter, observational clinical study. Setting: Eight private practice or outpatient sites in the United States and Mexico. Patients: Seventy subjects who had completed their 36-month follow-up in the AEGEA Pivotal Trial. Interventions: Diagnostic hysteroscopy. Measurements and Main Results: The subjects were screened for general health and infection and underwent diagnostic hysteroscopy. Menstrual bleeding status was recorded. The video of the hysteroscopic examination was analyzed by an independent reviewer, who assessed uterine cavity access and visualization of the cornua and tubal ostia as well as characterized adhesions on the basis of the criteria by March et al. An independent reviewer also subjectively assessed whether Pipelle endometrial biopsy or intrauterine device placement would be feasible. Uterine cavity access was achieved in 90% (63/70) of subjects. Among subjects with cavity access, the cornua and ostia were visualized in 79% (50/63) and adhesions were absent in 75% (47/63), with only 2 women having severe adhesions (3%, 2/63). Biopsy was projected to be feasible in 86% (62/70) and intrauterine device placement in 60% (42/70) of all subjects. The subjects' bleeding statuses were not correlated with uterine cavity access. The results were consistent for subjects with large uterine cavities and International Federation of Gynecologic and Obstetrics type II to VI myomas ≤4 cm. Conclusion: Water vapor endometrial ablation preserved an accessible uterine cavity and visualization of the ostia in most subjects, with minimal incidence of severe adhesions, a mean of 4 years after the ablation procedure.

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AEGEA Vapor-Based Endometrial Ablation: Perihysterectomy Proof of Concept

Cited by 3 publications

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Post-Ablation Cavity Evaluation: A Prospective Multicenter Observational Clinical Study to Evaluate Hysteroscopic Access to the Uterine Cavity 4 Years after Water Vapor Endometrial Ablation for the Treatment of Heavy Menstrual Bleeding

Post-Ablation Cavity Evaluation: A Prospective Multicenter Observational Clinical Study to Evaluate Hysteroscopic Access to the Uterine Cavity 4 Years after Water Vapor Endometrial Ablation for the Treatment of Heavy Menstrual Bleeding

Efficacy and safety of endometrial ablation for treating abnormal uterine bleeding in pre‐ and postmenopausal women with liver cirrhosis

Post-Ablation Cavity Evaluation: A Prospective Multicenter Observational Clinical Study to Evaluate Hysteroscopic Access to the Uterine Cavity 4 Years After Water Vapor Endometrial Ablation for the Treatment of Heavy Menstrual Bleeding

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