Sightline ColonoSight system for a disposable, power-assisted, non-fiber-optic colonoscopy (with video)

Background

The Sightline ColonoSight (CS) colonoscopy system presents 3 technologic advances: (1) disposable components protect the reusable parts from contact with colonic contents, eliminating the need for disinfection between procedures, (2) an air-pressure–powered engine assists in colonoscope advancement, (3) light emitting diode (LED) illumination eliminates the need for fiber optics and an external light source.

Objectives

To study the operation, performance, and safety of the Sightline CS colonoscopy system.

Design

The system was tested during colonoscopy in animals and in human pilot studies. An in vitro dye diffusion test, and bacterial cultures (obtained after using the colonoscope in animals and humans) were performed to ascertain the protective integrity of the disposable components.

Setting

Animal centers, hospitals in Israel and Italy, and office endoscopy centers in the United States.

Patients

Thirty-three volunteers and 145 patients who required a colonoscopy for various indications.

Interventions

Colonoscopy, polypectomy, biopsy, and coagulation.

Main Outcome Measures

Complications, system function, cecal intubation, and colonoscopy time.

Results

The Sightline CS system performed well during a colonoscopy in 19 animals and 178 patients, without complications. Dye studies and bacterial cultures showed no transfer of dye molecules or bacterial organisms across the protective, disposable components.

Limitations

This is an observational pilot study, with no comparative group.

Conclusions

The new Sightline CS colonoscopy system performed well. The disposable components eliminated the need for disinfection of the colonoscope between procedures. Advancement of the colonoscope in the colon was helped by self propulsion of the instrument affected by an air-pressure–powered engine. LED illumination eliminated the need for fiber optics and an external light source.

Abbreviations: CCD, charge-coupled device, CS, ColonoSight, FDA, Food and Drug Administration, IDC, instrument disposable cover, IRB, institutional review board, LED, light emitting diode, SCU, system control unit, TPC, thermal pinch cutter