{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T04:20:00Z","timestamp":1747196400116,"version":"3.40.5"},"reference-count":38,"publisher":"Public Library of Science (PLoS)","issue":"3","license":[{"start":{"date-parts":[[2023,3,17]],"date-time":"2023-03-17T00:00:00Z","timestamp":1679011200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Heracure Medical Ltd"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Objective<\/jats:title>\n<jats:p>Uterine size is one of the essential factors determining the feasibility of a minimally invasive gynecologic surgery approach. A traditional electromechanical morcellator is a well-known tool but not without flaws. We aim to assess feasibility and safety of a novel intrauterine power morcellation device for uterine size reduction to overcome these limitations during hysterectomy.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>This single-arm, observational study was conducted in a single tertiary care medical center from April 2022 to July 2022. Feasibility and safety of a novel intrauterine morcellation device for uterine size reduction was tested in ten post-hysterectomy uteri (Ex-vivo).<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Measurements and main results<\/jats:title>\n<jats:p>Ten uteri were examined in this trial. No major complications occurred during the procedure. All ten (10) uteri were successfully reduced in size (size reduction range was between 9% to 54%). The average resection time using the Heracure Device was 4.3 minutes (range: 1min\u2013 10min). Mean uterus weight reduction was 21%, with a mean circumference reduction of 25%. No leakage was observed from the outer surface of the uterus\/serosa after the saline injection post-procedure examination.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusion<\/jats:title>\n<jats:p>In this novel experiment, we verified the feasibility and safety of the Heracure device for vaginal intra-uterine morcellation for uterine size reduction. This technique could enable rapid and easy removal of the uterus through the vaginal orifice.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec005\">\n<jats:title>Clinical trial registration<\/jats:title>\n<jats:p>Name of the registry: ClinicalTrials.gov; Number Identifier: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05332132\" xlink:type=\"simple\">NCT05332132<\/jats:ext-link>.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0282149","type":"journal-article","created":{"date-parts":[[2023,3,17]],"date-time":"2023-03-17T17:34:22Z","timestamp":1679074462000},"page":"e0282149","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["An intrauterine cavity morcellator: A novel approach to high volume uterus morcellation. Ex-vivo study"],"prefix":"10.1371","volume":"18","author":[{"given":"Meir","family":"Pomeranz","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ron","family":"Schonman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yael","family":"Yagur","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rina","family":"Tamir Yaniv","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zvi","family":"Klein","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0447-2414","authenticated-orcid":true,"given":"Yair","family":"Daykan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2023,3,17]]},"reference":[{"key":"pone.0282149.ref001","article-title":"Surgical approach to hysterectomy for benign gynaecological disease","author":"JWM Aarts","year":"2015","journal-title":"Cochrane Database of Systematic Reviews"},{"key":"pone.0282149.ref002","first-page":"218","article-title":"Nationwide trends in the utilization of and payments for hysterectomy in the United States among commercially insured women","author":"DM Morgan","year":"2018","journal-title":"Am J Obstet Gynecol"},{"key":"pone.0282149.ref003","first-page":"224","article-title":"Trends in operative time and outcomes in minimally invasive hysterectomy from 2008 to 2018","author":"D Luchristt","year":"2021","journal-title":"Am J Obstet Gynecol"},{"key":"pone.0282149.ref004","article-title":"Hysterectomy: Let\u2019s Step Up the Ladder of Evidence to Look Over the Horizon","author":"A Giannini","year":"2022","journal-title":"Journal of Clinical Medicine. 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UPDATE: The FDA recommends performing contained morcellation in women when laparoscopic power morcellation is appropriate. In: Https:\/\/Www.Fda.Gov\/Medical-Devices\/Safetycommunications\/Update-Fda-Recommends-Performing-Contained-Morcellation-WomenWhen-Laparoscopic-Power-Morcellation. 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Vargas","year":"2015","journal-title":"J Minim Invasive Gynecol"},{"key":"pone.0282149.ref019","first-page":"42","article-title":"Morcellation During Total Laparoscopic Hysterectomies: Implications of the Use of a Contained Bag System","author":"A Gil-Gimeno","year":"2020","journal-title":"Journal of Obstetrics and Gynaecology Canada"},{"key":"pone.0282149.ref020","first-page":"63","article-title":"Tissue Extraction in Gynecologic Surgery: Past, Present, and Future","author":"C Foley","year":"2020","journal-title":"Clin Obstet Gynecol"},{"key":"pone.0282149.ref021","first-page":"25","article-title":"Preoperative Factors That Predict the Need to Morcellate in Total Laparoscopic Hysterectomy","author":"M Wolfe","year":"2018","journal-title":"J Minim Invasive Gynecol"},{"key":"pone.0282149.ref022","first-page":"61","article-title":"Predictive factors of the need to morcellate in total laparoscopic hysterectomy","author":"Z Asgari","year":"2021","journal-title":"Australian and New Zealand Journal of Obstetrics and Gynaecology"},{"key":"pone.0282149.ref023","first-page":"12","article-title":"Surgical approach to hysterectomy for benign gynaecological disease: Systematic review","author":"J. 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MDPI"},{"key":"pone.0282149.ref031","first-page":"125","article-title":"Transvaginal contained tissue extraction after laparoscopic myomectomy: a cohort study","author":"F Ghezzi","year":"2018","journal-title":"BJOG"},{"key":"pone.0282149.ref032","first-page":"21","article-title":"Electric Motorized Morcellator Versus Transvaginal Extraction for Myoma Retrieval After Laparoscopic Myomectomy: A Propensity-matched Analysis","author":"G Bogani","year":"2014","journal-title":"J Minim Invasive Gynecol"},{"key":"pone.0282149.ref033","article-title":"Outcome of occult uterine leiomyosarcoma after surgery for presumed uterine fibroids: A systematic review.","author":"EA Pritts","year":"2015","journal-title":"Journal of Minimally Invasive Gynecology"},{"key":"pone.0282149.ref034","first-page":"72","article-title":"Learning curve and surgical outcome for single-port access total laparoscopic hysterectomy in 100 consecutive cases","author":"J Paek","year":"2011","journal-title":"Gynecol Obstet Invest."},{"key":"pone.0282149.ref035","first-page":"284","article-title":"Transumbilical single-incision laparoscopic hysterectomy with conventional laparoscopic instruments in patients with symptomatic leiomyoma and\/or adenomyosis","author":"C Phongnarisorn","year":"2011","journal-title":"Arch Gynecol Obstet"},{"key":"pone.0282149.ref036","article-title":"Hysteroscopic morcellation of submucous myomas: A systematic review","author":"SG Vitale","year":"2017","journal-title":"BioMed Research International"},{"key":"pone.0282149.ref037","first-page":"12","article-title":"An Extremely Rare Case of Disseminated Peritoneal Leiomyomatosis with a Pelvic Leiomyosarcoma and Omental Metastasis after Laparoscopic Morcellation: Systematic Review of the Literature.","author":"A Vimercati","year":"2022","journal-title":"Diagnostics"},{"key":"pone.0282149.ref038","first-page":"23","article-title":"Effect of tumor morcellation in patients with early uterine sarcoma: a multicenter study in Germany","author":"G Gitas","year":"2022","journal-title":"Journal of the Turkish German Gynecology Association"}],"container-title":["PLOS ONE"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0282149","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,3,17]],"date-time":"2023-03-17T17:34:55Z","timestamp":1679074495000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0282149"}},"subtitle":[],"editor":[{"given":"Andrea","family":"Giannini","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2023,3,17]]},"references-count":38,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2023,3,17]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0282149","relation":{},"ISSN":["1932-6203"],"issn-type":[{"type":"electronic","value":"1932-6203"}],"subject":[],"published":{"date-parts":[[2023,3,17]]}}}