Cornering the Challenge: Initial Clinical Experience with EndoTheia FlexStone Endoscopic Steerable Basket

Area of Science:

• Urology
• Endourology
• Medical Devices

Background:

• The FlexStone device is an investigational, steerable stone basket designed for separate flexion from the ureteroscope.
• It aims to assist in stone retrieval without requiring an additional assistant during procedures.

Purpose of the Study:

• To evaluate the safety and feasibility of the novel FlexStone device for renal stone retrieval.
• To assess intraoperative and short-term postoperative adverse events.
• To determine surgeon workload and device performance during flexible ureteroscopy (URS).

Main Methods:

• A first-in-human clinical trial involving 10 patients undergoing URS for renal calculi.
• The FlexStone device was used for stone extraction or repositioning.
• Safety, successful basketing, adverse events, and surgeon workload (NASA-TLX) were primary and secondary endpoints.

Main Results:

• The FlexStone device successfully basketed target stones in 90% of cases.
• No intraoperative complications were observed; one patient required a second URS postoperatively without obstructing stone.
• Surgeons reported low mental, physical, and temporal demand, with low frustration and high overall performance ratings.

Conclusions:

• The preliminary investigation confirms the safety of the FlexStone steerable stone basket.
• The device shows potential as a valuable tool for urologists, particularly for complex caliceal anatomy and improving URS ergonomics.