Safety and efficacy of a novel miniaturized robotic assisted surgery system in hysterectomy: a prospective, investigational device exemption clinical trial.

To evaluate safety and effectiveness of the first-in-kind miniaturized surgical robotic platform, the MIRA Surgical System, in patients presenting with an indication for benign hysterectomy. A prospective, multi-center, multi-operator, non-randomized, consecutively enrolled Investigational Device Exemption Clinical Trial. Five surgeons participated across three types of institutions. Thirty-five patients with a mean age of 46.1 years (range 25-74) and a mean BMI of 29.2 kg/m² (range 21.5-41.5) were operated upon. Indications were menorrhagia (71.4%), fibroids (28.6%), and/or dysmenorrhea (25.7%). A total hysterectomy with uni-/bi-lateral salpingectomy was performed in 80%, a total hysterectomy with uni-/bi-lateral salpingo-oophorectomy in 14.3% and a total hysterectomy without adnexectomy in 5.7%. One subject required conversion to a laparoscopy due to a technical malfunction. Mean estimated blood loss was 52.6 ml (median 50 ml; range 10-200 ml). Specimens weighed from 31.2 g to 384 g (mean 136.1 g). No malignancies were identified. Vaginal-cuff closure was successfully completed in 34 cases, and completed vaginally in the converted case. Mean procedure duration was 141.8 min (median 127; range 73-273). Mean length of stay post-operatively was 5.0 h (median 3.5; range 1.3-29.4 h). Ten adverse events were reported: two intraoperative device-related and eight postoperative procedure-related (Seven Clavien-Dindo Grade-I, three Grade-II; no Grade-III or higher events). All resolved. The MIRA Surgical System demonstrated technical feasibility and an acceptable short-term safety profile in a selected cohort of patients undergoing benign hysterectomy. Evaluation in larger, diverse cohorts, with longer follow-up is required. (Registry: ClinicalTrials.gov, TRN: NCT06028542, Registration date: 16 August 2023.).