Magnetic balloon technology for solving colon loops: first in human clinical trial

Aims A colonoscopy CE marked add-on device (Endorail by Endostart srl, Certaldo, Italy) was developed to straighten loops and facilitate colonoscope positioning and progression. The aim of the study is to evaluate the safety and efficacy of magnetic balloon technology in solving colon loops.

Methods An open-label, not-controlled, prospective, single-center, interventional trial was conducted at Humanitas Research Hospital. Looping development and resolution was demonstrated by clinical judgement. Pain was recorded 30 minutes after the procedure using a visual analogue scale (VAS). A phone follow-up visit was scheduled after 7 days. Endorail is composed by a balloon catheter that can be inserted on demand in the 3,7 adult colonoscope tool channel, then filled with a syringe of ferromagnetic fluid and anchored with an external permanent magnet.

Results Six caucasian patients (42-64 yrs, 4 males, BMI: 19,6-24,1) were enrolled between February 11, 2020 and March 11, 2020. In 5 patients, magnetic anchorage was achieved, balloon undocking did not occur during the straightening maneuvers and the loop was always solved. One patient, due to the use of a colonoscope channel has been excluded from the analysis. All 6 patients regularly completed the colonoscopy. No device deficiencies or malfunctions occurred. No patient experienced pain within 30 minutes after completing the procedure (VAS: 0). None of the 6 participant patients experienced adverse.

Conclusions This first clinical study provided preliminary evidence that magnetic balloon technology is safe and effective in solving colon loops.

Publication History

Article published online:
14 April 2023