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Study Objective To evaluate the performance of a single-use, battery powered, operative hysteroscope in an office setting. Design Performance questionnaire survey with predefined scales (5 = very satisfied, 1 = very dissatisfied) Setting Procedure rooms in 15 US medical center. Patients or Participants Patients undergoing diagnostic and operative hysteroscopy Interventions The LiNA OperaScope is a single-use, battery operated system for see and treat hysteroscopy in the office and hospital setting. The 4.2 mm diameter cannula contains a miniature camera and LED illumination at the distal tip. The catheter tip is pre-curved and 360° steerable by a turning knob on the handle. The center of this turning knob is the insertion channel for hysteroscopic instruments up to 1.86 mm (5.5 Fr). Distention and flushing of the uterine cavity is facilitated with separate in-flow and out-flow channels with individual stopcocks at the handle. The HDMI cable at the bottom of the handle can be connected to an external monitor with HDMI input, or connected to the OperaScope Recording Module for recording of video or pictures to a standard USB drive. Measurements and Main Results 15 gynecologists completed the device performance questionnaire. 93% (14/15) were very satisfied and 7% (1/15) satisfied with the functionality of the device and its ease of insertion. All evaluators were satisfied or very satisfied with the quality of visualization. 93% (14/15) rated patient comfort and tolerability as very satisfying. The performance of the recording module was rated as satisfying by 78% (11/14), very satisfying by 14% (2/14) and neutral by 7% (1/14). All evaluators were overall very satisfied (10/15) or satisfied (5/10) with the device. Conclusion The OperaScope system can provide highly satisfying visualization of the endometrial cavity during diagnostic and operative hysteroscopic procedures. |
