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There were no procedures in which the users failed to perform laparoscopic pressure suturing of fibroids with the pressure-induced fibroid ischemia device. Improvement in the quality of life was evident in the Health-Related Quality of Life total, Energy\/Mood, Control, and Sexual Function domains of the Uterine Fibroid Symptom and Quality of Life questionnaire at 3\u00a0months post-procedure. Unanticipated risks were not identified. Serious adverse events were not identified. The initial clinical assessment of the pressure-induced fibroid ischemia device supports feasibility of the approach and does not reveal serious safety concerns. Trial is currently being registered retrospectively (This was a feasibility study and therefore registration was not mandatory).<\/jats:p>","DOI":"10.1007\/s43032-022-01033-7","type":"journal-article","created":{"date-parts":[[2022,8,8]],"date-time":"2022-08-08T19:02:42Z","timestamp":1659985362000},"page":"1366-1375","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pressure-Induced Fibroid Ischemia: First-In-Human Experience with a Novel Device for Laparoscopic Treatment of Symptomatic Uterine Fibroids"],"prefix":"10.1007","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2642-4296","authenticated-orcid":false,"given":"Michael G.","family":"Tal","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ran","family":"Keidar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gilad","family":"Magnazi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ohad","family":"Henn","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jin Hee","family":"Kim","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Scott G.","family":"Chudnoff","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kevin J.","family":"Stepp","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,8,8]]},"reference":[{"key":"1033_CR1","unstructured":"Hartmann KE, et al. 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