{"id":6745,"date":"2024-10-28T21:25:44","date_gmt":"2024-10-28T21:25:44","guid":{"rendered":"https:\/\/organonpro.com\/en-us\/?post_type=product&#038;p=6745"},"modified":"2025-08-11T15:35:05","modified_gmt":"2025-08-11T15:35:05","slug":"clinical-evidence","status":"publish","type":"product","link":"https:\/\/organonpro.com\/en-us\/product\/the-jada-system\/clinical-evidence\/","title":{"rendered":"Clinical Evidence"},"content":{"rendered":"\n<section class=\"wp-block-orc-two-column-block section-two-column-block-f4a77229-9635-48cb-9fd3-fe62062998f4\"><style>@media screen and (min-width: 940px){ .section-two-column-block-f4a77229-9635-48cb-9fd3-fe62062998f4 { margin-top: 0rem;margin-bottom: 0rem; }}@media screen and (min-width: 320px) and (max-width: 939px){.section-two-column-block-f4a77229-9635-48cb-9fd3-fe62062998f4 { margin-top: 0rem;margin-bottom: 0rem; }}<\/style><section class=\"splits splits-ratio splits-half splits-reverse ungated\" style=\"background-color:\"><div class=\"container\"><div class=\"splits-row row\"><div class=\"splits-figure   col-md-6 col-sm-6 \"><div class=\"mobile-active-banner h-100\"><div style=\"background-image:url(https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/102\/2024\/10\/3201a726a300ed42097544f535a40fb5.jpeg)\" class=\"splits-figure__bg ab lazy-bg img-for-desktop\"><\/div><div class=\"splits-figure__bg ab lazy-bg img-for-mobile\" style=\"background-image:url(https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/102\/2024\/10\/3201a726a300ed42097544f535a40fb5.jpeg)\"><\/div><\/div><\/div><div class=\"splits-area  col-md-6 col-sm-6\"><div class=\"splits-content cd\"><h4 class=\"splits-title xx\" style=\"color:\">Clinical evidEnce<\/h4><h2 class=\"splits-heading\">The Evidence Is In<\/h2><p class=\"splits-text\">The JADA<sup>\u00ae<\/sup> System was evaluated in two US clinical trials: the PEARLE study and the RUBY study.<\/p><div class=\"splits-button herobannerblock\"><div class=\"ungated\"><a class=\"btn btn-smoke__primary\" href=\"https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/6\/2024\/11\/Jada-Clinical-Study-Card-RUBY-Pearle.pdf\" rel=\"noopener noreferrer\" target=\"_blank \">Download Study Summaries<\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/section><\/section>\n\n\n\n<section class=\"wp-block-orc-two-column-block section-two-column-block-8419e9ee-27d1-4918-a8eb-d536e41b6141\"><style>@media screen and (min-width: 940px){ .section-two-column-block-8419e9ee-27d1-4918-a8eb-d536e41b6141 { margin-top: 0rem;margin-bottom: 0rem; }}@media screen and (min-width: 320px) and (max-width: 939px){.section-two-column-block-8419e9ee-27d1-4918-a8eb-d536e41b6141 { margin-top: 0rem;margin-bottom: 0rem; }}<\/style><section class=\"splits splits-ratio splits-half  ungated\" style=\"background-color:#ffffff\"><div class=\"container\"><div class=\"splits-row row\"><div class=\"splits-figure   col-md-6 col-sm-6 \"><div style=\"background-image:url(https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/102\/2024\/10\/ae5a4f427c835d9545f5a08d341a9534.png)\" class=\"splits-figure__bg ab\"><\/div><\/div><div class=\"splits-area  col-md-6 col-sm-6\"><div class=\"splits-content cd\"><h2 class=\"splits-heading\">The PEARLE Study<\/h2><p class=\"splits-text\">The PEARLE study was a prospective, multicenter, pivotal, single-arm study designed to assess the safety and effectiveness of the JADA System in treating primary postpartum hemorrhage and abnormal postpartum uterine bleeding, and enrolled 107 subjects.<sup>1<\/sup><\/p><div class=\"splits-button herobannerblock\"><div class=\"ungated\"><a class=\"btn btn-smoke__primary\" href=\"https:\/\/journals.lww.com\/greenjournal\/Fulltext\/2020\/11000\/Intrauterine_Vacuum_Induced_Hemorrhage_Control.4.aspx\" rel=\"noopener noreferrer\" target=\"_blank \">Read the Publication<\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/section><\/section>\n\n\n\n<section class=\"three-columns-callout\" style=\"background:#f8f8f8\"><div class=\"container\"><div class=\"row system-card-wrapper\"><div class=\"col-xl-4 col-lg-4 col-md-4 col-sm-4 col-12 \"><img decoding=\"async\" src=\"https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/102\/2024\/10\/effective.png\" alt=\"\"\/><div class=\"jada-system-card \" style=\"background-image:\"><h3>At controlling postpartum uterine bleeding<\/h3><p class=\"descript\">In the PEARLE study, 94% of participants met the primary end point: bleeding was controlled successfully with JADA, and no further intervention was required.<sup>1<\/sup>\n<br \/>\n<br \/>\n\n(n=100\/106)<\/p><\/div><\/div><div class=\"col-xl-4 col-lg-4 col-md-4 col-sm-4 col-12 \"><img decoding=\"async\" src=\"https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/102\/2024\/10\/recommend.png\" alt=\"\"\/><div class=\"jada-system-card \" style=\"background-image:\"><h3>Users said they would recommend JADA<\/h3><p class=\"descript\">Highly recommended among surveyed clinical investigators, in most cases using JADA for the first time.<sup>1<\/sup>\n<br \/>\n<br \/>\n(n=104\/107)<\/p><\/div><\/div><div class=\"col-xl-4 col-lg-4 col-md-4 col-sm-4 col-12 \"><img decoding=\"async\" src=\"https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/102\/2024\/10\/ease-of-use.png\" alt=\"\"\/><div class=\"jada-system-card \" style=\"background-image:\"><h3>In nearly every case, investigators rated JADA easy to use<\/h3><p class=\"descript\">Highly recommended among surveyed clinical investigators, in most cases using JADA for the first time.<sup>1<\/sup>\n<br \/>\n<br \/>\n(n=105\/107)<\/p><\/div><\/div><\/div><\/div><\/section>\n\n\n\n<section class=\"three-columns-callout\" style=\"background:unset\"><div class=\"container\"><div class=\"row justify-content-center text-center section-header-part\"><div class=\"col-xl-7 col-lg-7 col-md-7 col-sm-7 col-12\"><h5 style=\"color:#505050\">GET TO KNOW JADA<\/h5><h2 class=\"mb-0\">Bleeding Was Controlled Within 3 Minutes<\/h2><\/div><\/div><div class=\"row system-card-wrapper\"><div class=\"col-xl-4 col-lg-4 col-md-4 col-sm-4 col-12 border-separator\"><div class=\"jada-system-card with-bg-img\" style=\"background-image:url('https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/102\/2024\/10\/clock-1min.png')\"><h3>Uterine Collapse<\/h3><div class=\"counter-digits\">1 min.<\/div><p>(median time)<br>Uterine collapse observed<\/p><\/div><\/div><div class=\"col-xl-4 col-lg-4 col-md-4 col-sm-4 col-12 border-separator\"><div class=\"jada-system-card with-bg-img\" style=\"background-image:url('https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/102\/2024\/10\/clock-3min.png')\"><h3>Bleeding Controlled<\/h3><div class=\"counter-digits\">3 min.<\/div><p>(median time)<br>Bleeding controlled<\/p><\/div><\/div><div class=\"col-xl-4 col-lg-4 col-md-4 col-sm-4 col-12 \"><div class=\"jada-system-card with-bg-img\" style=\"background-image:url('https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/102\/2024\/10\/clock-3hrs.png')\"><h3>Treatment Completed<\/h3><div class=\"counter-digits\">3.2 hrs.<\/div><p>(median time)<br>Treatment completed and device removed<\/p><\/div><\/div><\/div><\/div><\/section>\n\n\n\n<section class=\"wp-block-orc-two-column-block section-two-column-block-1d0c2fee-0e2c-454f-be77-09ceb350ce04\"><style>@media screen and (min-width: 940px){ .section-two-column-block-1d0c2fee-0e2c-454f-be77-09ceb350ce04 { margin-top: 0rem;margin-bottom: 0rem; }}@media screen and (min-width: 940px){.section-two-column-block-1d0c2fee-0e2c-454f-be77-09ceb350ce04 section.splits{ padding-top: 5.6rem;padding-bottom: 5.6rem; }}@media screen and (min-width: 320px) and (max-width: 939px){.section-two-column-block-1d0c2fee-0e2c-454f-be77-09ceb350ce04 { margin-top: 0rem;margin-bottom: 0rem; }}@media screen and (min-width: 320px) and (max-width: 939px){.section-two-column-block-1d0c2fee-0e2c-454f-be77-09ceb350ce04 section.splits{ padding-top: 5.6rem;padding-bottom: 0rem; }}<\/style><section class=\"splits splits-ratio splits-floating splits-reverse ungated\" style=\"background-color:#ffffff\"><div class=\"container\"><div class=\"splits-row row\"><div class=\"splits-figure   col-md-6 col-sm-6 \"><div class=\"mobile-active-banner h-100\"><div style=\"background-image:url(https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/102\/2024\/10\/406c92d6f85cb6b5c6d3d1c27c52c119.png)\" class=\"splits-figure__bg ab img-for-desktop\"><\/div><div class=\"splits-figure__bg ab img-for-mobile\" style=\"background-image:url(https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/102\/2024\/10\/406c92d6f85cb6b5c6d3d1c27c52c119.png)\"><\/div><\/div><\/div><div class=\"splits-area  col-md-6 col-sm-6\"><div class=\"splits-content cd\"><h2 class=\"splits-heading\">Safety Profile<\/h2><p class=\"splits-text\">There were no adverse events deemed definitely related to the device or the procedure, and there was a low rate of possibly device-related adverse events.<\/p><div class=\"feature-chips\"><ul class=\"splits-lists\"><li class=\"splits-list\"><ion-icon name=\"checkmark-outline\" role=\"img\" class=\"md hydrated\" aria-label=\"checkmark outline\"><\/ion-icon><p>5 possibly device-related adverse events were rated as \u201cmoderate,\u201d and no event was rated as \u201csevere.\u201d<\/p><\/li><li class=\"splits-list\"><ion-icon name=\"checkmark-outline\" role=\"img\" class=\"md hydrated\" aria-label=\"checkmark outline\"><\/ion-icon><p>3 moderate events were cases of endometritis, which is a known risk of long labor, vaginal exam, and postpartum hemorrhage.<\/p><\/li><\/ul><\/div><div class=\"splits-button herobannerblock\"><div class=\"ungated\"><\/div><\/div><\/div><\/div><\/div><\/div><\/section><\/section>\n\n\n\n<section class=\"wp-block-orc-two-column-block section-two-column-block-d260068d-90b8-4bba-be34-223b62cfe18f\"><style>@media screen and (min-width: 940px){ .section-two-column-block-d260068d-90b8-4bba-be34-223b62cfe18f { margin-top: 0rem;margin-bottom: 0rem; }}@media screen and (min-width: 940px){.section-two-column-block-d260068d-90b8-4bba-be34-223b62cfe18f section.splits{ padding-top: 5.6rem;padding-bottom: 5.6rem; }}@media screen and (min-width: 320px) and (max-width: 939px){.section-two-column-block-d260068d-90b8-4bba-be34-223b62cfe18f { margin-top: 0rem;margin-bottom: 0rem; }}@media screen and (min-width: 320px) and (max-width: 939px){.section-two-column-block-d260068d-90b8-4bba-be34-223b62cfe18f section.splits{ padding-top: 0rem;padding-bottom: 0rem; }}<\/style><section class=\"splits splits-ratio splits-floating  ungated\" style=\"background-color:#ffffff\"><div class=\"container\"><div class=\"splits-row row\"><div class=\"splits-figure   col-md-6 col-sm-6 \"><div style=\"background-image:url(https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/102\/2024\/10\/5854e89193cea1041857246ee2e7724f.png)\" class=\"splits-figure__bg ab\"><\/div><\/div><div class=\"splits-area  col-md-6 col-sm-6\"><div class=\"splits-content cd\"><h2 class=\"splits-heading\">The Ruby Study<\/h2><p class=\"splits-text\">The RUBY Study was a multicenter, observational, post-market registry that\u00a0collected observational data on 800 patients treated with the JADA<sup>\u00ae<\/sup>\u00a0System from 16 US sites in the post-market setting.<\/p><div class=\"splits-button herobannerblock\"><div class=\"ungated\"><a class=\"btn btn-smoke__primary\" href=\"https:\/\/journals.lww.com\/greenjournal\/fulltext\/2023\/11000\/real_world_utilization_of_an_intrauterine,.4.aspx \" rel=\"noopener noreferrer\" target=\"_self\">Read the Publication<\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/section><\/section>\n","protected":false},"author":65,"featured_media":0,"parent":6739,"menu_order":0,"comment_status":"open","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"tags":[29,30],"product_categories":[],"product_specialization":[],"customer_type":[],"class_list":["post-6745","product","type-product","status-publish","hentry","tag-jada-system-efficacy","tag-jada-system-safety"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.11 (Yoast SEO v26.6) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Safety and Effectiveness of the JADA\u00ae System | Organon Pro<\/title>\n<meta name=\"description\" content=\"Find results from the latest clinical studies evaluating the safety and effectiveness for the JADA\u00ae System. 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