title: How to avoid risks for patients in minimal-access trials: Avoiding complications in clinical first-in-human studies by example of the ADBEE study.
abstract: A clinical trial is a prospective study designed to establish the safety and efficacy of investigational devices in humans, in accordance with the strict guidelines of the Food and Drug Administration (FDA; USA) or European Medicines Agency (EMA; Europe). Before a clinical first-in-human study is initiated, preclinical studies of the investigational product are mandatory, and the results should be sufficient to indicate that the investigational device is acceptably safe for the proposed evaluation in human subjects. The present paper describes an experience of clinical trials, highlighting ways of avoiding possible complications in clinical first-in-human studies. For a better approach to our aim, we exemplified a prospective, randomized, single-blind study, ADBEE. The primary objective was to assess the safety of the ADBLOCK system when used as an adjunct to laparoscopic primary removal of myomas in women wishing to improve pregnancy outcomes.
authors.affiliation: Clinic of Gynecology, Obstetrics and Gynecological Oncology, University Hospital for Gynecology, Pius-Hospital Oldenburg, Medical Campus University Oldenburg, 26121 Oldenburg, Germany.
authors.forename: Cristina
authors.initials: C
authors.lastname: Cezar
authors.affiliation: Johanna-Etienne-Clinic, Department for Obstetrics and Gynecology, 41462 Neuss, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Korell
authors.affiliation: Clinic for Minimal-Invasive Surgery, 14129 Berlin-Zehlendorf, Germany.
authors.forename: Garri
authors.initials: G
authors.lastname: Tchartchian
authors.affiliation: Clinic of Gynecology, Obstetrics and Gynecological Oncology, University Hospital for Gynecology, Pius-Hospital Oldenburg, Medical Campus University Oldenburg, 26121 Oldenburg, Germany.
authors.forename: Nicole
authors.initials: N
authors.lastname: Ziegler
authors.affiliation: Terumo Europe, Leuven 3001, Belgium.
authors.forename: Kazuhisa
authors.initials: K
authors.lastname: Senshu
authors.affiliation: Clinic of Gynecology, Obstetrics and Gynecological Oncology, University Hospital for Gynecology, Pius-Hospital Oldenburg, Medical Campus University Oldenburg, 26121 Oldenburg, Germany.
authors.forename: Anja
authors.initials: A
authors.lastname: Herrmann
authors.affiliation: Clinic of Gynecology, Obstetrics and Gynecological Oncology, University Hospital for Gynecology, Pius-Hospital Oldenburg, Medical Campus University Oldenburg, 26121 Oldenburg, Germany.
authors.forename: Angelika
authors.initials: A
authors.lastname: Larbig
authors.affiliation: Clinic of Gynecology, Obstetrics and Gynecological Oncology, University Hospital for Gynecology, Pius-Hospital Oldenburg, Medical Campus University Oldenburg, 26121 Oldenburg, Germany. Electronic address: rudy-leon.dewilde@pius-hospital.de.
authors.forename: Rudy Leon
authors.initials: RL
authors.lastname: De Wilde
mesh_terms: D000328:Adult; D003912:Dextrins / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005782:Gels; D006801:Humans; D007247:Infertility, Female / Q000209:etiology / Q000601:surgery; D010535:Laparoscopy / Q000009:adverse effects*; D007889:Leiomyoma / Q000150:complications / Q000601:surgery*; D011108:Polymers / Q000009:adverse effects / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D012307:Risk Factors; D016037:Single-Blind Method; D000267:Tissue Adhesions / Q000209:etiology / Q000517:prevention & control*; D014594:Uterine Neoplasms / Q000150:complications / Q000601:surgery*
chemical_list: D003912:Dextrins; D005782:Gels; D011108:Polymers
keywords: ADBLOCK system; adhesions; clinical trials; complications; safety and efficacy