CLINICAL TRIAL
A clinical trial of the SoloScope colonoscope system is currently underway in Tel-Aviv Sourasky Medical center. Results so far demonstrated that the operation of the colonoscope is safe and very similar to conventional colonoscope. The system requires minimal training. Visualization is excellent enabling physicians to see larger areas of the colon mucosa in one view.
For more information on the clinical trial, please contact us.
”The current configuration of the SoloScope Colonoscope System allows for therapeutic interventions with high quality and efficacy. The operation of the system is very convenient. We did not see any technical problems and my general impression is excellent, including subjects with challenging anatomy and polypectomy.”
​
​
Nathan Gluck, MD. Ph.D., Head of GI Malignancies Service
Tel-Aviv Sourasky Medical Center
Clinical and Pre-Clinical Trial Results
Previous Self-Propelled Version of the SoloScope System
PRE-CLINICAL
2014 randomized in vivo Visualization Study in Swine
CLINICAL
​
A clinical evaluation of the SoloScope was conducted in 2013 at a Tel Aviv hospital to determine the safety and cecal intubation rate of success.
Highlights
​
-
Prospective patients presenting for colorectal cancer screening underwent Self-Propelled Disposable Colonoscope immediately followed by Conventional Colonoscope
-
Excellent results were achieved in the trial
-
FDA clearance obtained September 2014
Publications
​
PRE-CLINICAL
​
2014 randomized in vivo Visualization Study in Swine
Highlights
​
-
Beads surgically implanted to mimic pathologies in 12 swine
-
Training to operate the SoloScope System and visualize pathologies completed in half a day
-
Two physicians performed three SoloScope colonoscopies and two conventional colonoscopies randomly on each subject
-
Two additional physicians performed video reviews of all procedures.
-
Randomization of all study parameters (swine, number and size of beads per swine, order of procedures, procedure rooms, physicians)
-
No difficulty in reading procedure videos on the SoloScope System display was reported
Publications
​
Superior Visualization of SoloScope Colonoscopy vs Conventional Colonoscopy
In Detecting 453 Implanted Pathologies (Beads)
In all beads
2.6x Lower Miss Rate (p=0.002)
% Miss rate
5.1%
13.2%
SoloScope Colonoscopy
Conventional Colonoscopy
In cliniclly significant beads
(beads >6mm)
4.0x Lower Miss Rate (p=0.022)
10.5%
% Miss rate
2.6%
SoloScope Colonoscopy
Conventional Colonoscopy