Minimally Invasive Benign Hysterectomy Surgical Technique Using the MIRA Surgical System Under Ide-Study Protocol.

Abstract

Study Objective

To assess device performance and safety of the MIRA Surgical System (Virtual Incision, Nebraska, USA) when used to robotically assist in benign hysterectomy surgery.

Design

International, prospective, multi-center, multi-operator, non-randomized, consecutively enrolled clinical investigation.

Setting

The study will be conducted in four centers in Switzerland and the U.S. (NCT06028542)

Patients or Participants

Adult females following informed consent indicated for hysterectomy for benign disease. Uterine size ≤16 weeks. BMI <40 kg/m². Weight ≥45.4kg. Height ≥152cm. ASA grades I-III. Sample size, n=35, was selected to provide at least 80% chance to observe at least one safety event if the event occurs in at least 5.3% of subjects. Post-operative follow-up is 42 days(±7days).

Interventions

The video demonstrates the components of the system. Insertion and deployment of the Minibot are illustrated. Subsequently, the video showcases the procedure's essential steps: dissection and exposure is achieved with the bipolar graspers and monopolar scissors. The infundibulopelvic ligament and the uterine artery are dissected, coagulated and transected. Following creation of the bladderflap a colpotomy is performed and uterus and ovaries are removed vaginally. The procedure is completed by closing the vaginal cuff using the needle driver and grasper.

Measurements and Primary Results

The primary efficacy endpoint is the successful completion of the procedural steps in >31/35 patients. Safety analyses will be based on the intra- and post-operative adverse events. Secondary outcome measures include: estimated blood loss, length of stay, cuff tissue healing, readmission and reoperation rates, number of ports, ancillary tools used (+reason). In US sites a secondary laparoscopic camera at the level of the upper abdomen will capture a panoramic view to enable an independent observer and the DSMB to document off-screen movement of the RAS device to determine whether a correlation exists between tissue interactions and adverse events.

Conclusion

The video exemplifies the effective use of the MIRA Surgical System in a total hysterectomy and bilateral salpingo-oophorectomy.