A motor-driven single-use colonoscope controlled with a hand-held device: a feasibility study in volunteers

Background

Several new instruments have been developed in the effort to improve the acceptance of colonoscopy for colorectal cancer screening. A new colonoscope, the Invendoscope, is presented here. It consists of an endoscopic sheath with an inverted sleeve, instrument channel, and an electrohydraulic deflecting tip. The instrument is steered by a hand-held device and propelled by a motorized drive unit.

Objective

Our purpose was to evaluate the feasibility of the new Invendoscope SC40.

Design

Prospective single-arm pilot study over 2 time periods using 2 different instrument prototypes (170 and 180/200 cm).

Patients

Thirty-four healthy volunteers (19 men, mean age 49.7 years). Technical instrument defects led to premature termination in 5 additional volunteers during the 2 study periods (4 in phase 1, 1 in phase 2), who were excluded from further analysis.

Interventions

Total colonoscopy was attempted, with all procedures being performed without sedation.

Main Outcome Measurements

Cecal intubation rate.

Results

The cecum was reached in 82% of the 34 cases (95% CI, 66%-92%), with better results in period 2 than in period 1 (90% vs 79%); of the 6 incomplete examinations, 4 reached the mid transverse colon or beyond and 2 were stopped in the sigmoid colon because of pain. The volunteer rating showed a mean score of 1.96 (range 1-6; 1 = no discomfort). No complications were encountered.

Limitations

No data regarding diagnostic accuracy and no data comparing the instrument with conventional colonoscopy are available as yet.

Conclusions

This pilot proof-of-principle study of a new motor-driven colonoscope showed promising cecal intubation rates and an absence of pain in 92% of cases. Further clinical and comparative studies are warranted.