Sightline ColonoSight system for a disposable, power-assisted, non-fiber-optic colonoscopy (with video) - 23/08/11

Doi : 10.1016/j.gie.2007.12.062

Moshe Shike, MD ^⁎, Zvi Fireman, MD, Rami Eliakim, MD, Ori Segol, MD, Alan Sloyer, MD, Lawrence B. Cohen, MD, Sharon Goldfarb-Albak, BSc, Alessandro Repici, MD
Current affiliations: Memorial Sloan-Kettering Cancer Center (M.S.), New York, New York University School of Medicine (A.S.), New York, North Shore University Hospital (A.S.), Manhasset and Glen Cove, The Mount Sinai School of Medicine (L.B.C.), New York, New York, USA, Hillel Yaffe Medical Center (Z.F.), Hadera, Rambam Medical Center (R.E.), Haifa, Carmel Medical Center (O.S.), Haifa, Stryker GI (S.G.-A.), Haifa, Israel, IRCCS Instituto Clinico Humanitas (A.R.), Milan, Italy

Reprint requests: Moshe Shike, MD, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY 10021.

Hadera, Haifa, Israel, Torino, Italy, Long Island, New York, New York, USA

Abstract

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.

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Abbreviations : CCD, CS, FDA, IDC, IRB, LED, SCU, TPC

Plan

Patients and methods

Components of the Sightline CS system

Assembly of the Sightline CS system

Operation of the Sightline CS system

Examination of the colon and interventions

Animal studies

Microbial barrier testing

Studies in volunteers and patients

Statistical analysis

Results

Microbial barrier testing

Studies in volunteers and patients

Discussion

Presented at Digestive Disease Week May 15-20, 2004, New Orleans, Louisiana (Gastrointest Endosc 2004;59:113), and the New York Society for Gastrointestinal Endoscopy Annual Course, December 16, 2005, New York, New York.