Office diagnostic smart hysterofiberscopy, hysmartscopy, using mobile technology: A single center experience and analysis of diagnostic accuracy.

Abstract

Office hysteroscopy is a minimally invasive procedure and provides a direct view of the endometrial cavity. This study presents the first report of a novel smartphone‑based ultrathin flexible hysterofiberscopy system (currently known as office diagnostic smart hysterofiberscopy, or Hysmartscopy), for the diagnosis of intrauterine abnormalities. The Hysmartscopy system captures images using a flexible fiberscope (0.8 mm in diameter) coupled with an Apple iPhone 6S™. This study was conducted at the Department of Gynecology of Nara Medical University Hospital from February, 2015 to February, 2019. In total, 22 patients requiring a diagnostic Hysmartscopy for the investigation of intrauterine pathology were included in this study. In the first cohort, Hysmartscopy was performed in the operating room with anesthesia in 17 patients to assess the overall physician's experience during image acquisition, subjective image quality and the ease of use on a 5‑point Likert scale. In the second cohort, 5 subjects further underwent Hysmartscopy without anesthesia to evaluate the feasibility and safety of this system. Images were assessed by two expert gynecological endoscopists blinded to the pathological reports. The Hysmartscopy system revealed good resolutions in the ex vivo image and color resolution. From the beginning of the procedure, the time required to capture a video was <1 min. The ergonomic advantage of this technique enabled the examiners to use direct visualization for image‑guided diagnosis in a hand‑held manner. On average, the quality of the images (4.0/5.0 on a 5‑point Likert scale) may be largely sufficient to detect emergent findings. The diagnostic accuracy of Hysmartscopy was found to be 100% (2/2) for the normal endometrium, 71.4% (5/7) for endometrial polyps, 62.5% (5/8) for submucosal fibroids and 100% (5/5) for endometrial cancer. The diagnostic accuracy of Hysmartscopy was 77.3%. None of the cases had any complications during and after the diagnostic procedures. Thus, the results indicate that Hysmartscopy is a patient‑friendly technique without the need for anesthesia and cervical dilation in an office setting. To the best of our knowledge, this study is first proof of concept pilot study of Hysmartscopy. Hysmartscopy may prove to be a simple, convenient, non‑invasive, accurate and well‑tolerated procedure for the diagnosis of intrauterine abnormalities that can be performed within an outpatient clinic.