The study involves the planned use of a new microwave-based device during colonoscopy procedures in 50 patients to assess the performance and safety of its use for detection of colorectal polyps and lack of normal clinical practice modification. The device is a final design version, which has been previously tested in several preclinical studies (including phantom studies, an ex vivo study with human tissues, and an in vivo study with porcine model) and in a pilot study in humans (NCT05477836)
None
Patients at a high risk of having major complications as perforation or hemorrhage, suspected or proven lower gastrointestinal bleeding, non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure, inadequate bowel cleansing.
ASA-IV patients.
Urgent colonoscopy.
Single group
MiWEndo System
DeviceAll colonoscopies will be performed with high-definition technology. The MiWEndo System will be fitted to the tip of the endoscope before colonoscopy is started and connected to the microwave processor unit. Endoscopies will be performed by experienced endoscopists who will be previously trained on the use of the MiWEndo System. The MiWEndo Analyzer will be managed by the assistant. At the beginning of the extubation, the MiWEndo System will be turned on and the endoscopist will put music headphones on (blind to the results of MiWEndo). In case one of them identifies a polyp, the exploration will be stopped and check if it has been detected by the alternative method as well. All the polyps will be resected and sent to the Pathological Department for histological analysis following the usual clinical practice. A stopwatch will be used to measure both total procedure time and withdrawal time.
Number of polyps
With MiWEndo assisted colonoscopy, detect at least one polyp before colonoscopy in 10% of patients.
Number of adverse events.
Number of adverse events related with the use of the MiWEndo using the lexicon proposed by the American Society of Gastrointestinal Endoscopy (ASGE) (Cotton PB et al. GIE 2010;71:446-54).
Number of mural injuries.
Mural injuries related with the use of the MiWEndo.
Number and size (adenomas and polyps).
The number and size of all lesions (adenomas and all polyps) detected with MiWEndo-assisted colonoscopy.
True positives (TP), False positives (FP), False negatives (FN).
The concordance with the lesions detected by the standard colonoscopy (TP, FP, FN).
Patients' comfort.
Patients' feedback related to colonoscopy using the Gloucester comfort score that ranges from 1 (no discomfort) to 5 (severe discomfort).
Perception of difficulty.
Perception of difficulty by the endoscopist based on a 5-points Likert scale (very easy to very difficult or very much to very little).
Click on the lead sponsor to view all of their trials.
