{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T03:45:43Z","timestamp":1791776743176,"version":"4.3.4"},"reference-count":30,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T00:00:00Z","timestamp":1789084800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T00:00:00Z","timestamp":1789084800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100001858","name":"VINNOVA","doi-asserted-by":"publisher","award":["2020\u201004743"],"award-info":[{"award-number":["2020\u201004743"]}],"id":[{"id":"10.13039\/501100001858","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001858","name":"VINNOVA","doi-asserted-by":"publisher","award":["2024\u201001909"],"award-info":[{"award-number":["2024\u201001909"]}],"id":[{"id":"10.13039\/501100001858","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100013297","name":"Eurostars","doi-asserted-by":"publisher","award":["2021\u201003291"],"award-info":[{"award-number":["2021\u201003291"]}],"id":[{"id":"10.13039\/100013297","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"published-print":{"date-parts":[[2026,11]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To evaluate the feasibility, safety and diagnostic performance of outpatient management of recurrent non\u2010muscle\u2010invasive bladder cancer (NMIBC) under local anaesthesia using the Multi4 instrument, a series of preclinical studies were performed followed by a first\u2010in\u2010human clinical investigation. NMIBC is associated with frequent recurrence, requiring repeated transurethral resection of the bladder (TUR\u2010B) under anaesthesia, resulting in substantial healthcare burden. The Multi4 instrument integrates local anaesthesia injection, diathermy biopsy, coagulation and automated tissue retrieval. The primary objective was to determine whether Multi4 provides histologically evaluable biopsies in an outpatient setting, and secondary objectives included safety, usability, patient\u2010reported outcomes and health\u2010economic impact.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Preclinical\n                      <jats:italic>in vivo<\/jats:italic>\n                      evaluation was performed in 13 pigs to assess safety, biopsy quality, coagulation efficacy and perforation risk. A prospective, open\u2010label, single\u2010arm clinical investigation enrolled 18 adults with recurrent Ta\/T1 NMIBC (\u226410 mm lesions). Procedures were performed under local anaesthesia using flexible cystoscopy. The primary endpoint was the proportion of evaluable biopsies. Secondary endpoints included adverse events, usability, pain (0\u201310 scale), EQ\u20105D and cost comparison versus standard TUR\u2010B. Diagnostic yield was also assessed at the patient level.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 550 porcine biopsies demonstrated immediate haemostasis and preserved tissue architecture suitable for histological assessment. Perforation occurred after 7\u201311 sequential biopsies at the same location, indicating a wide safety margin. Clinically, 134\/145 biopsies (92%) were evaluable and the primary endpoint was met. Diagnostic yield per patient was 89%. No device\u2010related adverse events or Clavien\u2013Dindo complications occurred. All procedures were completed under local anaesthesia without conversion to standard TUR\u2010B or use of additional instruments. The median pain score was 0.5\/10. Estimated per\u2010procedure cost reduction was 73\u201389% versus TUR\u2010B.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Multi4 enables feasible and safe outpatient biopsy and lesion management of small recurrent NMIBC under local anaesthesia with substantially reduced resource use while maintaining diagnostic reliability.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bju.70445","type":"journal-article","created":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T12:46:29Z","timestamp":1789130789000},"page":"867-876","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["First\u2010in\u2010human outpatient management of recurrent\n                    <scp>NMIBC<\/scp>\n                    with the Multi4 instrument"],"prefix":"10.1111","volume":"138","author":[{"given":"Miden","family":"Melle\u2010Hannah","sequence":"first","affiliation":[{"name":"Multi4 Medical AB  Gothenburg Sweden"},{"name":"Department of Urology, Institute of Clinical Sciences Sahlgrenska Academy, Gothenburg University  Gothenburg Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6441-4729","authenticated-orcid":false,"given":"Henrik","family":"Kj\u00f6lhede","sequence":"additional","affiliation":[{"name":"Department of Urology, Institute of Clinical Sciences Sahlgrenska Academy, Gothenburg University  Gothenburg Sweden"},{"name":"Department of Urology Sahlgrenska University Hospital  Gothenburg Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henrik","family":"B\u00e4ckdahl","sequence":"additional","affiliation":[{"name":"RISE Research Institutes of Sweden Life Science, Medical Device and Diagnostics  Bor\u00e5s Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8510-3102","authenticated-orcid":false,"given":"Martin E.","family":"Johansson","sequence":"additional","affiliation":[{"name":"Department of Clinical Pathology Sahlgrenska University Hospital  Gothenburg Sweden"},{"name":"Sahlgrenska Center for Cancer Research University of Gothenburg, Sahlgrenska Academy  Gothenburg Sweden"},{"name":"Department of Laboratory Medicine, Institute of Biomedicine University of Gothenburg, Sahlgrenska Academy  Gothenburg Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4270-8475","authenticated-orcid":false,"given":"Joakim","family":"H\u00e5kansson","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Institute of Biomedicine University of Gothenburg, Sahlgrenska Academy  Gothenburg Sweden"},{"name":"RISE Research Institutes of Sweden Life Science, Medical Device and Diagnostics  Bor\u00e5s Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,11]]},"reference":[{"key":"e_1_2_12_2_1","volume-title":"Estimated number of new cases in 2020, worldwide, both sexes, all ages","author":"Cancer IAfRo","year":"2021"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21660"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000008300"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.urology.2022.12.009"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0302-2838(02)00068-4"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1080\/00365590902808541"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2021.08.010"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.3109\/21681805.2015.1085089"},{"key":"e_1_2_12_10_1","unstructured":"urinv\u20acagscancer SnkfoU\u2010o (SNRUBC).2021Available from:https:\/\/statistik.incanet.se\/Urinblasecancer\/."},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2015.08.037"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1464-410X.2002.02776.x"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00345-013-1045-z"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00428-015-1739-2"},{"key":"e_1_2_12_15_1","unstructured":"Cancercentrum.Transuretral resektion av urinbl\u00e5secancer TUR\u2010B. 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